According to a Sept. 20 question and answer document about Ortho Evra on the FDA Web site, the revision to the label includes a new bolded warning about higher estrogen exposure.

As many of you may be aware, the Center for Constitutional Litigation has been assisting plaintiffs' counsel in litigating the FDA preemption issue in Perry v. Novartis, a case alleging that Novartis' failure to warn of the carcinogenic nature of Elidel, its topical treatment for dermatitis, led to the Perry's two-year-old son's lymphoma. After Novartis moved to dismiss on preemption grounds, Judge Stewart Dalzell in the Eastern District of Pennsylvania invited the FDA to submit an amicus brief on the preemption issue.

The FDA today submitted its letter brief and, in my view, it represents a significant retreat from the broad preemption position the agency took in the January regulatory preamble. The FDA expressly disclaims any intention to "occupy the field" and makes clear that failure-to-warn claims that do not directly conflict with FDA regulatory decisions remain viable. I will try to get the letter posted to the preemption library but, for the time being, here are some relevant excerpts that are of broad applicability:

"A manufacturer may not deviate from FDA-approved product labeling except in limited circumstances. If the manufacturer of a non-generic prescription drug wishes to add or strengthen a warning, the manufacturer may provide FDA with a supplemental submission regarding the proposed labeling change, providing a full explanation of the basis for the proposed change. . . . If FDA has not rejected the supplement within 30 days after its submission, the manufacturer may distribute the drug with the new proposed labeling. . . . Even after the drug has been distributed, FDA may choose to reject the proposed labeling change and may order the drug manufacturer to cease distributing drugs with the new label. . .

If a drug manufacturer has 'reasonable evidence of a causal association' between the use of a drug and a 'clinically significant hazard,' the manufacturer has an obligation to seek FDA approval for a labeling change, in order to add a warning of the new potential hazard." (p. 3, citations and footnotes omitted).

"A failure-to-warn claim is not preempted merely because it imposes liability for a manufacturer's failure to provide a warning that has not yet been required by the FDA. Federal regulations explicitly recognize that manufacturers can, and in some limited instances must, modify their labels to add new warnings of hazards associated with the drug, without awaiting prior FDA approval. . . . Where, in light of new scientific evidence or other changed circumstances a drug label no longer ensures safe and effective use, FDA encourages manufacturers to work quickly and collaboratively with the agency to make necessary labeling changes." (p. 10)

A Plano, Texas woman who suffered a miscarriage and developed potentially life-threatening blood clots after using the Ortho Evra(R) birth control patch has filed a federal lawsuit against drug manufacturing giant Johnson & Johnson in Marshall, Texas.

Elizabeth Barroso, now 24, began experiencing chest pains and difficulty breathing after using Ortho Evra(R) for only three weeks in 2004. She spent eight days in the hospital, where doctors treated her for blood clots in her lungs. Ms. Barroso had no prior history of such problems.

After being released, Ms. Barroso was prescribed blood-thinning medication for 10 months. She became pregnant in October 2004, but later suffered a miscarriage. When she later became pregnant in 2005, Ms. Barroso was forced to endure daily self-injections of blood thinners to prevent another miscarriage. Due to her injuries from Ortho Evra(R), all of Ms. Barroso's future pregnancies will carry a risk of miscarriage and will require similar treatment.

"This young lady's life was put in jeopardy by a company that made a harmful product," says John David Hart of the Law Offices of John David Hart in Fort Worth, Texas. "And the tragic thing is the company continues to market and sell this product even today."

The case is the latest of many against Johnson & Johnson, which earlier this year settled other cases involving Ortho Evra(R) and the development of blood clots.

The complaint filed in U.S. District Court in the Eastern District of Texas, Marshall Division, says the package insert that came with Ortho Evra(R) was misleading and in direct conflict with Johnson & Johnson's own data. The insert suggests the risk of blood clots among Ortho Evra(R) users is equivalent to that of women using oral contraceptives.

However, from April 2002 to December 2004, the company logged 27,974 adverse events among Ortho Evra(R) users. During that same time period, Johnson & Johnson noted only 5,571 adverse events for one of its oral contraceptives, even though it was used three times more than Ortho Evra(R).

5th Circuit: Jury Should Decide Adequacy Of Risk Warning; Off-Label Use Creates Duty
NEW ORLEANS - A jury should decide whether the label for Wyeth's gastroesophageal reflux disease (GERD) drug Reglan misled doctors about the risk of involuntary muscle conditions, a panel of the Fifth Circuit U.S. Court of Appeals ruled Aug. 22 (Sue C. McNeil v. Wyeth, et al., No. 05-10509, 5th Cir.).
The panel dismissed Wyeth's arguments that it need not warn doctors and patients about mere associations with adverse effects or about problems resulting from off-label use.
Sue C. McNeil was prescribed Reglan in August 2000 for treatment of GERD. Although the drug is approved for no more than 12 weeks' use, three doctors continued prescriptions for 14 months.
The pharmacology section of Reglan's label explained that it may produce "extrapyramidal reactions, although these are comparatively rare." The label also warned that Reglan may produce tardive dyskinesia, a severe form of extrapyramidal symptoms (EPS), marked by involuntary movements of the mouth and extremities and general agitation.

The Associated Press Attorneys for Merck & Co. want to see records that could show the extent of a juror's financial relationship with a plaintiff who won a $32 million verdict against the company. Jose Manuel Rios testified in a post-trial deposition to borrowing up to $10,000 interest free from the widow of Leonel Garza, who had a fatal heart attack after taking the painkiller Vioxx. Plaintiffs attorneys had hailed the case as the first in which a U.S. jury found short-term Vioxx usage a factor leading to a heart attack.

Parker & Waichman, LLP announced that it has filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of the estate of a 26-year-old woman. The decedent died from an acute pulmonary embolism after using the Ortho Evra birth control patch from November 26, 2002 to July 8, 2003. The suit was filed in the United States District Court for the Eastern District of Michigan.

For more information on Ortho Evra and this case, see this Ortho Evra article.

US Report Faults FDA Post-Approval Study Tracking

WASHINGTON (Reuters) Jul 10 - The U.S. Food and Drug Administration does not know the status of many post-approval studies promised by drug makers and does not make tracking them a top priority, a report released on Friday said.

The inspector general at the Department of Health and Human Services said the FDA should improve its monitoring of the studies by upgrading its tracking systems and asking manufacturers to provide better information.

Most studies are promised voluntarily by drug makers to learn more about benefits or side effects after medicines reach the market. Forty-eight percent of drug applications approved from 1990 to 2004 involved at least one post-approval study commitment, the inspector general's report said.

Companies are supposed to give FDA annual reports on the progress of their studies. The inspector general said 35 percent of 336 annual reports due in 2004 "were missing entirely or contained no information on open postmarketing study commitments." The FDA validated only 30 percent of the reports, the report said.

"FDA cannot readily identify whether or how timely postmarketing study commitments are progressing toward completion," the report said.

FDA reviewers who were interviewed "indicated to us that monitoring postmarketing study commitments is not generally considered a top priority," the report said.

The FDA cannot force companies to complete the voluntary studies, but the agency said it had taken steps to improve monitoring and make some information public.

FDA critics have complained for years that drug makers often fail to follow through on promised post-approval studies. Some have called on Congress to give the FDA more power to punish drug makers that leave studies unfinished.

In comments submitted to the inspector general, the FDA said it took "very seriously" its responsibility for monitoring post-approval studies.

The agency agreed it could make improvements but disputed the finding that it could not tell the status of many studies. It said it had improved a database of post-approval research and was training staff on confirming information in companies' annual reports.

The FDA also has hired an outside contractor to make recommendations on ways to make sure companies complete more the studies.

The fact that Ortho McNeil has marketed the drug as a safe and easy alternative to regular birth control pills has been misleading and irresponsible. Did this pharmaceutical company do its research? Was the information it received about the risks associated with the Ortho Evra patch reliable?

Doctors discovered multiple blood clots in her leg and lungs, and kept her in the hospital for two weeks, during which time she underwent two procedures and a surgery. After assessing the health issues of this otherwise healthy runner and karate black belt, doctors pointed to her use of the Ortho Evra birth control patch as the cause of her clots.

Aspirin is the mainstay of primary and secondary stroke prevention. The rate of cerebrovascular events such as ischemic stroke and TIA after discontinuation of aspirin has not been clearly studied in a case-controlled fashion. Aspirin is usually discontinued before elective surgical procedures, because it increases complications by prolonging bleeding times and increasing operative blood loss. Anecdotal evidence indicates that strokes can occur when patients discontinue either warfarin or aspirin. It is not clear, however, whether this apparent association is coincidence, a result of transient hypercoagulability from surgical procedures, or caused primarily by the discontinuation of antithrombotic medication.

These levels of estrogen in the blood stream have been known to cause blood clots, pulmonary embolisms, heart attacks, strokes, and even death! Women should be warned of these birth control patch side effects and dangers, and not just told that it's a safe alternative to regular birth control pills.

The studies consistently found that patients of generalists were at greater risk of mortality from both cardiac and noncardiac risk factors and had higher unadjusted mortality rates. Studies varied as to whether or not generalists had higher mortality rates after adjusting for risk factors.

Study Finds Ways to Improve Detection of Blood Clots in the Lung
Enhancing Diagnostic Tests Could Reduce Deaths from Pulmonary Embolism

A new study of a commonly used imaging test of the chest to detect potentially deadly blood clots in the lung shows that extending the scan to the legs - where the clots typically originate - or adding a standard clinical assessment significantly improves physicians' abilities to accurately diagnose pulmonary embolism. A sudden and potentially deadly blockage in a lung artery, pulmonary embolism affects an estimated 600,000 Americans each year, making it the fourth most commonly occurring cardiovascular problem in the United States. The multicenter study was funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Subarachnoid hemorrhage (SAH) implies the presence of blood within the subarachnoid space from some pathologic process. SAH occurs in various clinical contexts, the most common being head trauma. The common medical use of the term SAH refers to the nontraumatic types of hemorrhages, usually from rupture of a berry aneurysm or arteriovenous malformation (AVM). The scope of this article is limited to these nontraumatic hemorrhages.

SAH comprises half of spontaneous atraumatic intracranial hemorrhages, the other half consist of bleeding that occurs within the brain parenchyma. Intracranial hemorrhage as a whole comprises 20% of all strokes. SAH is a devastating condition with high morbidity and mortality, and, in the United States, it is associated with an annual cost of $1.75 billion. The silver lining is that the condition often presents with a so-called "warning leak" that leaves the patient neurologically intact. Diagnosis and intervention during this stage of the disease is associated with an excellent outcome. Consequently, clinicians must be on the lookout for clinical presentations that suggest a leaking aneursym or malformation.
Risk factors include cigarette smoking and heavy alcohol consumption. Although hypertension has been identified as a risk factor for aneurysm formation, the data with respect to rupture are conflicting. However, certain hypertensive states, such as those induced by use of cocaine and other stimulants such as amphetamines, clearly promote aneurysm growth and rupture earlier than would be predicted by the available data.

Some of these suits and future lawsuits may be consolidated in an "MDL" or multi-district litigation in the near future.

Birth control pills introduced in the 1960's had a much higher dose of Estrogen than was deemed necessary to achieve the desired results. By 1961, doctors were observing much higher risks with blood clots causing heart attacks and strokes and in the years that followed, the doses of Estrogen delivered were lowered significantly.

While at law school, Robert was an Associate Editor on the University of Florida Law Review, and recipient of the Florida Trial Lawyers Association Essay Award for his published article, Municipal Tort Liability: Sovereign Immunity and Access to the Court, Fla. Trial Lawyers Assoc. J. (May 1982). Mr. Blanchard is licensed to practice law before all Florida state courts, and the Federal courts for the Northern and Middle Districts of Florida and the Eleventh Circuit Court of Appeals. He is a member of the Escambia-Santa Rosa Bar Association and the Academy of Florida Trial Lawyers.

Blood Clots,
Strokes,
Heart Attacks,
Pulmonary Embolisms, and
Deep Vein Thrombosis, aka DVT

The severity of Ortho Evra's side effects first came to light in April 2004 when an 18-year-old New York fashion student died while using the patch. Her autopsy revealed that

A young woman of 23 years old, Jessie D'Amato of Connecticut, suffered massive blockage of her right pulmonary artery after just 9 months on the patch, resulting in two surgeries. Another, Tammy Leitheiser, died after suffering clots in both right and left pulmonary arteries. Many users of the patch are coming forward to complain about the lack of education on the risks of using the patch. A slick campaign featuring sexy super model Naomi Campbell helped sell the patch to hundreds of thousands of woman around the world, many of whom want answers.

Ortho Evra was introduced to the public in 2001 as the first transdermal (skin) patch approved for birth control. The weekly prescription releases the hormones progestin and estrogen through the skin into the blood stream to prevent pregnancy. In 2005, Ortho McNeil, the patch's maker and a subsidiary of Johnson & Johnson, issued a warning to the millions of women using Ortho Evra revealing that the patch exposes them to significant amounts of estrogen and may place them at risk of developing blood clots.

A stroke occurs in a persons brain, and is caused by loss of oxegyn to brain tissues. A stroke is usually the result of a blood clot or ruptured blood vessel in the brain and can cause severe injuries or death. Stroke symptoms include, but are not limited to, partial paralysis, memory loss, pain, loss of cognitive functions. If you or someone you know has suffered any of these stroke symptoms, regardless of using the Ortho Evra birth control patch, seek medical help immediately.

Robert Blanchard received his undergraduate degree from the University of West Florida in 1978, and his law degree from the University of Florida in 1983.

How does Ortho Evra prevent pregnancy?
The weekly prescription patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin into the blood stream to prevent pregnancy.

When was Ortho Evra approved?
The U.S. Food and Drug Administration approved Ortho Evra, manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson, in November 2001.

In November 2005, Ortho McNeil, a subsidiary of Johnson & Johnson, issued an Ortho Evra birth control patch warning to millions of women revealing that the patch exposes them to significant amounts of the hormone estrogen (about 60 percent more than regular birth control pills) and may put them at greater risk of developing blood clots. According to Ortho Evra attorneys involved in lawsuits filed against the patch’s maker, the U.S. Food and Drug Administration (FDA) has received over 20 reports of blood clots and other adverse events associated with the use of the Ortho Evra birth control patch.

Ortho Evra lawsuits point to the large amount of estrogen released by the patch (about 60 percent more than the pill) as the cause of blood clots, many of which lead to fatal heart attacks and strokes. If you believe you have suffered some of the dangerous side effects associated with taking the Ortho Evra Birth Control Patch, it may be important to contact an attorney today.

The number of lawsuits filed on behalf of sufferers of serious side effects resulting from the use of the patch is currently around two dozen, but the number may grow much higher, according to some attorneys and medical experts familiar with lawusits involving defective or dangerous drugs.

We cannot guarantee that you will receive a response to any inquiry you submit through this site. If you believe you have a legal claim, please be aware that there are deadlines and statutes of limitation which must be met or you may lose your opportunity to pursue your claim. Time is of the essence and we urge you to act. If you do not find help through this site, seek immediate assistance elsewhere.