Leslie Niedner

Leslie cannot remember who first raised the question of whether Adrianna was on the birth control patch. But the suggestion sent her searching the Internet for answers. She quickly found dozens of other stories like Adrianna’s – of healthy young women on the Ortho Evra transdermal contraceptive patch who mysteriously suffered sometimes fatal heart attacks, strokes or blood clots.

“Why would they prescribe this?” Leslie asked the Boston Globe. The question is even more painful to ask, knowing that that thousands of lawsuits have mounted against Johnson & Johnson, makers of the Ortho Evra patch, by women who have been injured or died after using the patch. Johnson & Johnson has paid $70 million to settle the lawsuits.

The bad press has dropped sales of the patch by 75 percent, but the drug is still approved for use by the Food and Drug Administration. “It’s needlessly dangerous,” says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization in Washington, during an interview with UPI.

The birth control patch was marketed to younger women because the weekly patches provide a more convenient alternative to daily birth control pills. However, those patches have been found to deliver far more estrogen than birth control pills, Those higher estrogen levels can double a woman’s risk of blood clots.

SOURCE: Ortho Evra and Blood Clots › Mother of Ortho Evra user asks why her daughter had to die

Johnson & Johnson, which makes the Ortho Evra (norelgestromin/ethinyl estradiol) Transdermal System, has been the focus of hundreds of lawsuits filed over the past two years by women who suffered blood clots and other serious side effects from heightened estrogen levels caused by the birth control patches. Some reports include fatalities. J&J has already settled several of the lawsuits, and the company has told plaintiffs attorneys it is ready to settle remaining ones.

The new labeling on the Ortho Evra packaing includes
- CONTRAINDICATIONS – The term “significant hypertension” was replaced with actual blood pressure values.
- WARNINGS – Under “Elevated Blood Pressure,” providing more complete guidance to health care providers regarding use in women with hypertension.
- ADVERSE REACTIONS – Under “Clinical Trial Experience, Postmarketing Experience,” editorial revisions to provide for use of MedDRA terminology and a more user-friendly format.

The Ortho Evra patch was approved by the FDA in 2001. In 2008, J&J updated its labeling on the birth control patch after testing revealed women between the ages of 15 and 44 on the patch are at higher risk for pulmonary embolism. Serious side effects related to Ortho Evra include heart attack or stroke; blood clots in the legs, lungs (pulmonary embolism), or eyes, or in the deep veins of the legs; chest pain, breast cancer or cancer of the lining of the uterus, cervix or vagina; liver tumor (benign or cancerous); severe high blood pressure; and diabetes with complications of the kidneys, eyes, nerves or blood vessels.

SOURCE: Ortho Evra and Blood Clots › New warnings, adverse reactions added to Ortho Evra

The B-12 patchs, made by global nutraceticals company VitaSciences, are sold as an alternative to oral supplements and shots. The company has applied for a patent on the patch and mentions on its Web site a clinical study involving six volunteers. Each patch contains 1,000 micrograms of vitamin B-12 and is designed to be worn once a week for no more than 24 hours. The dime-sized patches are worn on the neck behind the earlobe.

The patches deliver nutrients into the circulatory system by absorption through the skin. A special membrane controls the rate at which the nutrients are absorbed, allowing the active ingredient to release at a consistent rate over a period of time.

But can that delivery system be trusted? Other patch-delivery systems have come under scrutiny lately for seeping too much of the active ingredient into the blood stream. Drug maker Johnson & Johnson has settled numerous lawsuits in both the United States and Canada over its contraceptive patch Ortho Evra. The patch was found to leak too much estrogen into the blood stream causing blood clots which led to strokes and even death in some women.

Earlier this year the company’s pain patch, Druagesic fentanyl, was recalled for leaking too much medicine into some people who used them. That overdosing caused addictions and deaths in some users. While the fentanyl patch has been recalled, Ortho Evra is still widely available for use as birth control.

Vitamin B-12 toxicity, or having too much vitamin B-12 in your system, is uncommon but can have serious side effects. Side effects of vitamin B-12 toxicity include diarrhea, feeling of swelling over the entire body, blood clots in the legs and signs of an allergic reaction such as hives or rash; itching; swelling of the lips, mouth or throat; wheezing or other difficulty breathing.

The B-12 patch is still in a testing phase, and there don’t seem to be any reports so far of adverse reactions, but it is important to be aware of possible dangers based on experience from this type of delivery method. Those who suspect vitamin B-12 toxicity should consult a medical professional.

Sources:
VitaSciences
E Med TV

SOURCE: Ortho Evra and Blood Clots › Consumers should use caution with B-12 vitamin patch

Transdermal patches were introduced in the 1990s initially for birth control, as a treatment for angina or heart failure, and for smoking cessation. Today, drug patches have branched out to other approved therapies including neurology, pain management and urology and some, like the nicotine patch, are now available over the counter as well.

Patches offer an alternative delivery system that may benefit some consumers. For example, the Ortho Evra birth control patch is marketed to younger women who would rather wear the patch that is changed weekly instead of taking a daily pill. However the delivery system of some patches have raised serious questions about their safety.

In January, we told you about Johnson & Johnson recalling its Duragesic fentanyl pain patch – the fifth recall of the pain patches since 1994 – because it leaked too much medicine into the bloodstream, making it highly addictive and resulting in deaths. The same company’s birth control patch, Ortho Evra, has also been blamed for leaking too much medicine into the bloodstream leading to pulmonary embolisms and strokes. The company already has settled several lawsuits charging that its Ortho Evra birth control patch has caused serious harm and even death.

Pharma Live says the demand for prescription drug patches is on the rise, especially among the elderly who may forget to take medications and may benefit from the patch system. Let’s hope the serious injuries caused by such patches don’t rise as well.

SOURCE: Ortho Evra and Blood Clots › More drug patches expected to hit market, but are they safe?

EVRA’s product information now includes average daily release rates for norelgestromin (200 micrograms every 24 hours) and ethinyl estradiol (35 micrograms every 24 hours). This information replaces the previously labeled daily delivery rate of norelgestromin (150 micrograms every 24 hours) and ethinyl estradiol (20 micrograms every 24 hours). The term “release rate” has also replaced the prevous term “delivery rate” as a more descriptive term regarding release of hormones from the patch.

The new data was derived by measuring the hormone content that remained in the EVRA patches worn by women for 7 days. The previously labeled delivery rate information was estimated using a different method. The company reports that there has been no change to the way the patch is made, and there is no known impact on the safety and effectiveness of the patch as a result of the new information on the average daily release rate.

In November 2006, Health Canada issued a letter to health care professionals warning of the risk of venous thromboembolism in users of Ortho Evra and expressed that the same warning should apply to EVRA. Studies have found that the patches can leak too much medicine into the blood stream, causing blood clots that can lead to strokes and even death.

To date, more than 500 lawsuits have been filed on behalf of women who suffered blood clots and other serious side effects from taking Ortho Evra. Recently, drug maker Johnson & Johnson settled lawsuits with Canadian women harmed by the birth control patch.

Sources:

Janssen-Ortho, Inc.
Health Canada

SOURCE: Ortho Evra and Blood Clots › Canadian groups issue label change on birth control patch

Those discounts had been slashed because of a 2005 federal law designed to save taxpayers money on Medicaid reimbursements for drugs. An unfortunate side effect of that law financially dissuaded pharmaceutical companies from selling their products to these pharmacies at reduced prices. So women began to see contraceptive pills and product costs rise from $5 to $10 a month to $30 to $50 a month.

These findings are encouraging for college women in particular. Since the 2005, college either passed the price increase to students or stopped selling contraceptives all together. Some were concerned students would turn to less preferred contraceptives or use nothing at all.

Last month we told you that Texas Christian University (TCU) had forged a deal with drug companies so that it could start offering discounted contraceptives to its students. More colleges are expected to follow suit now and swing deals with pharmaceutical companies. But buyer beware – clinics are still offering the Ortho Evra birth control patch, a popular choice for younger women who don’t want the hassle of a once-a-day pill. The patch, made by Johnson & Johnson, has caused serious health problems and even death in young women – a trend that has caused some consumer groups to petition the FDA to stop the sale of the birth control patch. Johnson & Johnson no longer markets the patch, however it is still widely available and has yet to be pulled from the market.

Source: Associated Press

SOURCE: Ortho Evra and Blood Clots › New provision would help lower cost of contraceptives for college students

The Plan First! program is an outreach by the Wayne County Department of Public Health and targets low-income women between the ages of 19 and 44 who are U.S. citizens or qualified legal residents, are not currently pregnant and are not covered by Medicaid or other family planning coverage.

The Plan First! program offers a wide variety of women’s health services such as office visits, pap tests, breast exams, lab tests, medications, treatment of sexually transmitted diseases and sterilization referrals. It also provides women with birth control options such as the pill, the Ortho Evra contraceptive patch, condoms, vaginal contraceptive ring, spermicide, barrier method and natural family planning.

With birth control costing consumers as much as $50 a month, many low income women may choose to go without it and take their chances with an unwanted pregnancy.

“In today’s environment, higher education and a stabilizing career have become even more important to women and families,” said a spokesperson with the health department. “Controlling the timing of a pregnancy is one of the keys to a bright and promising future.”

However, women should carefully consider birth control methods before choosing one that’s right for them. While convenience and personal beliefs weigh heavy on a decision, so should the safety of the product. Birth control pills come with a sight risk of blood clots, but research has shown that the birth control patch, sold under the brandname Ortho Evra, carries a greater risk of serious health problems, such as blood clots that have lead to stroke and even death in young women.

While contraceptive patch maker Johnson & Johnson has shelled out millions to settle lawsuits from women who were injured by the patches both in the United States and Canada, the drug is still available on the market and prescribed to women.

SOURCE: Ortho Evra and Blood Clots › Plan First! offers free health services, birth control

Johnson & Johnson

The Ortho Evra patch was originally marketing to young women who were turned off by the notion of taking a once-daily pill for contraception. The patch is replaced after a week. However, the patch was found in some cases to seep too much estrogen into the bloodstream, which can cause serious health problems.

As an emerging pattern of young women suffering from pulmonary embolisms and strokes emerged, health experts began to point fingers at Johnson & Johnson. Despite the settlements in both the U.S. and Canada, the patch is still on the market and doctors are still prescribing it.

Ortho Evra was first approved for marketing and sale in Canada in 2002. Since then, at least 16 cases of blood clots and one heart attack among women who were using the patch have been reported. Two patients died, including a 16-year-old girl, according to Health Canada.

The Canadian lawsuits involve 22 women from Ontario, British Columbia and Quebec; however, anyone else with a valid claim can still come forward and be included in the settlement. The Canadian plaintiffs sought C$400,00 each in compensation and C$20 million in punitive damages.

The lawsuit claims that Johnson & Johnson failed to properly warn patients and doctors that its Ortho Evra contraceptive patch has a higher risk of blood clots, strokes and heart attacks compared to the birth control pill.

An Ontario judge will be asked to end the suit at a hearing March 23.

SOURCE: Ortho Evra and Blood Clots › J&J settles lawsuits with Canadian women harmed by birth control patch

The clinical trails were held in Australia with 40 women testing a number of skin spray formulations to the forearm once a day over 14 days. The formulations contained the proprietary new generation progestin Nestorone combined with either ethinyl estradiol or estradiol as the estrogen. The amount of each of these hormones in the blood was measured once a day and every four hours on day 14.

These were the first trials to test the performance of daily sprays over an extended period of time. Earlier trials tested only single doses of Nestorone MDTS formulations. Trial results showed that formulations containing Nestorone and ethinyl estradiol successfully delivered therapeutic amounts of both hormones across the skin into the blood. All spray formulations were well tolerated with no serious adverse events recorded, according to the drug maker.

The next step is expected to be a Phase 2 dose-ranging clinical trial before conducting Phase 3 global registration trials.

SOURCE: Ortho Evra and Blood Clots › Contraceptive spray touted as safer alternative to pills, patches

“Another issue is that contraceptive choice isn’t just a clinical decision, it’s a lifestyle one and it should be promoted this way to women much more than it currently is,” says Julie Bentley, Chief Executive of FPA.

Perhaps another reason why women should take a closer look at their birth control method is the potential health risks it may carry. Women simply cannot trust the FDA to ensure the safety of a product. Of particular concern is the Ortho Evra Contraceptive Transdermal Patch. The patch is one of the newer types of birth control targeting younger women who don’t want mess with the hassle of taking a pill everyday.

The patch’s makers, Johnson & Johnson, however, are facing numerous lawsuits from young women or their family members who have suffered serious side effects such as blood clots, strokes and even death. Some of the lawsuits have already been resolved, ending in confidential settlements. Johnson & Johnson says it is ready to work out settlements in the other lawsuits it faces.

Advocacy groups have petitioned the FDA to pull the patches from the marketplace, but the patches are still available and doctors continue to write prescriptions for them.

SOURCE: Ortho Evra and Blood Clots › Women should spend more time weighing risks of birth control options

However, students may want to weigh their contraception options more closely. Johnson & Johnson, the makers of the Ortho Evra contraceptive patch has been riddled with lawsuits claiming the patches cause serious side effects in young women, such as blood clots and even death. The patches reportedly can leak too much estrogen into the bloodstream causing the serious health problems.

According to reports, several lawsuits against the company have already ended with confidential settlements and Johnson & Johnson has already told plaintiffs attorneys that it is ready to work out settlements with the others it faces.

The Ortho Evra patch was originally marketed to women seeking an alternative to the once-daily birth control pill. However, since its debut there has been an emerging pattern of young women suffering from pulmonary embolisms and strokes.

Johnson & Johnson no longer actively markets the patch, but it is still available and has yet to be pulled from the market despite petitions by consumer group Public Citizen to the FDA to remove the product. The group also claims removal of the patch would have an environmental benefit, as the discarded patches could leak contaminants into the environment after they are disposed of by consumers.

SOURCE: Ortho Evra and Blood Clots › TCU students urged to heed contraception patch warnings

This is the fifth recall of Duragesic fentanyl patch since 1994. Patches have caused much pain for Johnson & Johnson. Last year, the company paid $68 million to settle lawsuits against the company’s birth control patch, Ortho Evra. The patch was linked to at least 40 deaths caused by blood clots.

Ortho Evra was originally marketed to women seeking an alternative to a one-daily birth control pill. The patch system was designed to deliver the same level of estrogen as the birth control pill, but its delivery system was different. Pills are taken orally and are processed through the liver before reaching the blood stream. The medication on the patch is applied directly to the skin and is not diffused by the body before reaching the blood stream. In contrast to the birth control pill, the patch delivers 60 percent more estrogen to the patch-wearer’s blood system. And that, according to the numerous lawsuits filed, is where the problems begin.

Despite an emerging pattern of young women suffering from pulmonary embolisms and strokes, Johnson & Johnson continued to market the patch, running advertisements that at times did not include warnings of serious, life-threatening side effects.

While Johnson & Johnson no longer markets Ortho Evra, the birth control patch is still available and has yet to be pulled from the market.

SOURCE: Ortho Evra and Blood Clots › Another J&J patch causing deaths in users

Clinical data show that the Ortho-Evra patch carries greater risks compared to standard contraception in pill form without providing any real benefits. Public Citizen’s petition listed several reasons why the patch should be banned, including:

• Potentially toxic levels of synthetic estrogen, up to 60% more on average
• Greater variability in estrogen levels than standard oral birth control / inconsistent dosages depending on where on the body the patch is applied
• A substantially higher risk of blood clots: studies indicate that Ortho Evra users were twice as likely to develop venuous thrombosis – life-threatening blood clots in the leg that are fatal if they migrate to the lungs
• Higher risk of side effects such as breast discomfort, severe menstrual pain, nausea, and vomiting
• Higher than usual discontinuation rates; chances of women discontinuing usage due to side effects and irritation caused by wearing the patch are estimated at 50%
• The same results as oral birth control but with harsher side effects and greater risks

The consumer group also argues that a ban on the patch would be environmentally sound. Discarded patches, it notes, contain 80% of the original estrogen dose that threaten to leak and contaminate the environment after disposal.

The group concludes that if Ortho Evra were a pill, its side effects and greater risks would not be tolerated by the FDA.

SOURCE: Ortho Evra and Blood Clots › consumer group urges Ortho Evra ban

Currently there is litigation pending throughout the United States, including in Chicago, relating to the use of the Ortho Evra patch. Plaintiffs have filed claims after suffering from blood clots, pulmonary embolisms and in some cases death. The side effects of the patch can be very serious and even deadly.

If you or someone you know developed blood clots while being on the Ortho Evra patch, contact an attorney immediately to learn your legal rights. You may be able to file a claim against the manufacturer for the injuries suffered.

January 31st, 2008 by Gary MaCallister with injuryboard.com

SOURCE: Ortho Evra and Blood Clots › Ortho Evra birth control patch label change

In a response to a question posed by U.S. District Court in Toledo, which is considering a federal lawsuit stemming from Johnson & Johnson’s Ortho Evra birth-control patch, the court’s majority found that the General Assembly had the authority to enact the law.

“Some may think limitations on certain damages to be unwise legislative policy-making, but it is beyond the authority of any court to write into the Constitution that which was not installed there by the framers and ratified by the people,” wrote Chief Justice Thomas Moyer.

He was joined in the majority by Justices Evelyn Lundberg Stratton, Maureen O’Connor, Judith Lanzinger, and Robert Cupp. Justices Paul Pfieifer and Terrence O’Donnell dissented.

“If a damage cap of $250,000 is constitutional – the majority opinion mentions the amount but never discusses it, apparently giving it no significance – why can’t the General Assembly limit damages for claims they do not favor to $100,000? Or $1,000? Or $10?” asked Justice Pfeifer, part of the now long-gone 4-3 majority that struck down a similar law in 1999.

“Under the court’s reasoning, there is nothing in the Ohio Constitution that restrains the General Assembly from limiting non-economic damages to $1…,” he wrote. “After today, what meaning is left in a litigant’s constitutional right to have a jury determine damages?”

Justice O’Donnell opined that the General Assembly has unconstitutionally substituted its judgment for that of a jury through Senate Bill 80, opening the door for further encroachments in the future.

Melisa Arbino, of Cincinnati, suffered a series of potentially fatal blood clots in her brain and lungs in 2005 that she maintains were the result of side effects from the hormonal patch. Ortho Evra remains on the market, but its label warns that it could lead to serious side effects.

The law does not limit damages in catastrophic cases, such as those involving paralysis or loss of limb.

It also does not limit economic damages – lost wages, medical costs, and other measurable out-of-pocket damages – in less serious cases.

The law, however, does cap harder-to-quantify non-economic damages for such things as pain, suffering, and mental anguish at $250,000, or three times the economic damages up to a maximum of $500,000 arising out of the injury, $350,000 of which could go specifically to the injured person.

The law was backed by Ohio’s business community, which cited prior decisions striking down such caps as reasons to remake the court through elections. Four justices have joined the court since the 1999 ruling.

Although not a part of this case, the ruling is likely to bolster the argument that different caps put in place under a medical malpractice tort-reform law are also constitutional.

December 27th, 2007 by JIM PROVANCE with toledoblade.com

SOURCE: Ortho Evra and Blood Clots › Ohio Supreme Court upholds law that puts cap on personal injury damages

It likely hints at the company’s desire to avoid trials where its actions -or lack thereof – regarding safety problems with the defective Ortho Evra birth control patch could be called into question.

When Ortho Evra was introduced in 2002, Johnson and Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives.

But in 2005, the Food & Drug Administration warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who used oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra.

Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

Since then, Ortho Evra has been named in well over 2,000 lawsuits, and the suit filed by 14-year-old Alycia Brown’s family is one of them. According to Bloomberg News, Alycia died in May 2004 from two blood clots in her lungs that developed after she had been using the Ortho Evra birth control patch for several weeks.

According to court records obtained by Bloomberg, Johnson & Johnson settled with her family for $1.25 million. The court records said that Johnson & Johnson did not admit that Ortho Evra had caused Alycia’s death, and that the company settled in order to avoid litigation. Neither Johnson & Johnson nor Alycia’s family would comment to Bloomberg, as both sides had signed a confidentiality agreement.

Johnson & Johnson is likely desperate to keep such agreements secret because it has been accused of ignoring warning signs that Ortho Evra was dangerous. There is evidence that such accusations are true, including the testimony of Joe Lippman, a former employee of and a plaintiff in a whistle blower lawsuit against Johnson & Johnson.

Lippman raised concerns over “dangerously high levels of estrogen” that users of the patch were exposed to in the late 1990s. Lippman, who was fired in 2006, claims his concerns were ignored.

October 25th, 2007

SOURCE: Ortho Evra and Blood Clots › Ortho Evra lawsuit settled for $1.25m as J&J tries to avoid public trials

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.

Confidentiality Order

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.

Warning Signs

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.”

October 24th, 2007

SOURCE: Ortho Evra and Blood Clots › J&J pays $1.25m to settle lawuit over death of 14-year-old