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?

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

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

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