Ortho Evra Attorney
Former VP sues Johnson & Johnson over firing
Category: Ortho Evra Legal News
An AP news wire last week announced that a former executive with Johnson & Johnson subsidiary Ortho-McNeil is suing the company over his firing. The ex-VP for the company claims he repeatedly sought recalls for defective drugs, including the Ortho Evra birth control patch.
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Ortho Evra lawsuits reach 400 in U.S.
Category: Ortho Evra Legal News
According to an NBC4.com report, an additional Ortho Evra lawsuit has been filed against Ortho McNeil, a division of Johnson & Johnson, for injuries related to the use of the company's birth control patch.
FDA Updates Ortho Evra Label
Category: Ortho Evra Warnings
In September 2006, the FDA decided to update the Ortho Evra birth control patch label to reflect a serious warning to women using it. The updated label cites a study that shows that use of the patch can double a woman's risk of blood clots and other complications, when compared with use of birth control pills.
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.
Is the FDA Clarifying It's Position on Preemption?
Category: Ortho Evra Legal News
Under George Bush, the FDA decided to conspire with the drug makers to make sure no one could sue over their dangerous medications. Unable to change the law in the courts, or even in the Republican Congress, the FDA just unlaterally wrote a preface to its recent rule changes saying that once the FDA approves a drug, the subject is totally preempted by Federal law. This preface contradicted years of settled law and even the FDA's own prior pronouncements on the topic. A recent letter the FDA wrote to on Judge however may halp clarify their position.
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)
Continue reading "Is the FDA Clarifying It's Position on Preemption?"
Texas Women Sues Over Patch Injuries
Category: Ortho Evra Legal News
Yet another lawsuit has been filed. Allegations that the Ortho Evra Patch causes dangerous pulmonary emboli will not go away until Johnson & Johnson changes to a safer formulation.
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).
Court Rules on Drug Warning Labels
Category: Ortho Evra Legal News
There is a pretty good decision from the 5th Circuit about adequacy of warnings being a jury issue. Off label use and other concepts are discussed as well.
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.
CLients Who Live in a Small Town
Category: Ortho Evra Legal News
If you are making an Ortho Evra injury claimand live in a small town, be careful not to make loans to people who may end up sitting on the jury in your case. See this article about a Texas Juror Took Loans From Plaintiff in Vioxx Case:
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.
Still No Change in Formulation
Category: Ortho Evra Warnings
Despite knowledge so strong that the FDA required a warning that the Ortho Evra Patch is dispensing overdoses of estrogen to unsuspecting women, the manufacturer still has made no change in design for the U.S. market. Other countries have the patch, but in lower doses of estrogen, making it safer for risks of strokes, blood clots and heart attacks. Why isn't the FDA acting on this important health issue? Is it because they are bought and paid for by pharmaceutical money?
MDL Attorneys Press On
Category: Ortho Evra Attorneys and Law Firms
Attorneys working in the Ortho Evra Multi District Litigation proceedings are diligently pursuing discovery from the product manufacturer. PSC member Ray Chester, a leader in the litigation, has asked that his MDL work be considered as concluded and his co-members on the PSC all appreciate the great work he has done in showing the defects of this product.
More lawsuits filed on Ortho Evra Patch
Category: Ortho Evra Legal News
Here is another news report of a pulmonary embolism case:
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.
What is the FDA Doing?
Category: Ortho Evra Legal News
When a company proposes to market a drug, the FDA will often let them go forward on the promise that they will conduct further studies on the safety of the drug. Unfortunately, it appears that the FDA never follows up to see if these promises are kept. As a result, too many people are injured before a drug gets pulled from the market.
As reported,
US Report Faults FDA Post-Approval Study TrackingWASHINGTON (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.
Should There Be an Ortho Evra Recall?
Category: Ortho Evra Legal News
To date, there has not been a recall on the Ortho Evra birth control patch, which which was approved by the FDA in 2001 and has been used by more than four million women since that time. There have been hundreds of serious side effects reported by women using the patch, including blood clot, heart attack, plumonary embolism, stroke and more. There have also been a number of deaths reported and more than 100 lawsuits filed against maker Ortho McNeil, a subsidiary of Johnson and Johnson.
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?
Ortho Evra Blood Clots Continue
Category: Ortho Evra Legal News
A recent story out of New Jersey brings more Ortho Evra blood clots to light. Twenty-year-old college student Kristin Ribakusky-Templin rushed to the emergency room at her local hospital after two weeks of leg pain had gotten so bad she was unable to walk.
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.
MDL Lawyers Press On
Category: Ortho Evra Attorneys and Law Firms
While defense counsel continues to press for Federal Court involvement in state court cases, attorneys for the Plaintiffs continue to gather medical records and other information on their clients' injuries. One thing the company is going to have to explain is why they have only added a stronger warning to the product, but have not changed its composition in the US to match the safer forms in other countries.
Aspirin and Stroke
Users of the Ortho Evra birth control patch may wonder if their stroke was cause by something other than the estrogen. Here is one possibility I read about: Stopping Aspirin May Cause Strokes.
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.
Why Does More Estrogen Exposure Increase Risk?
Category: Ortho Evra Medical Information
The Ortho Evra birth control patch raises great concern because of its extremely high estrogen exposure to patients. Some studies have shown that the patch releases up to three times as much estrogen as birth control pills.
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.
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Heart Attack Treatment - Get a Specialist
Category: Ortho Evra Medical Information
Heart attack is one of the injuries that can arise from the Ortho Evra Patch.
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.
Continue reading "Heart Attack Treatment - Get a Specialist"
Severe Ortho Evra Risks
Category: Ortho Evra Warnings
Despite the comfort level women seem to have with birth control, some forms of it can cause serious side effects and even death. The Ortho Evra patch, manufactured by Ortho-McNiel, a division of Johnson and Johnson, significantly increases users' exposure to estrogen, which in turn increase the risk of blood clots and death.
Johnson & Johnson Settles 30 Lawsuits
Category: Ortho Evra Legal News
A May 13, 2006 L.A. Times news story reported that Johnson and Johnson settled Ortho Evra lawsuits with 30 women who claimed they developed blood clots while using the birth control patch. Recent studies reported that women using Ortho Evra were exposed to 60% more estrogen than women using oral contraceptives, and that these women were twice as likely to develop blood clots on Ortho Evra vs. The Pill.
Detection of Blood Clots in the Lung
Category: Ortho Evra Medical Information
Jerry Parker was kind to send me the following article which may benefit those with an injury from the Ortho Evra birth control patch:
Study Finds Ways to Improve Detection of Blood Clots in the Lung
Enhancing Diagnostic Tests Could Reduce Deaths from Pulmonary EmbolismA 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).
New Treatment for Strokes
Category: Ortho Evra Medical Information
Ortho Evra users may be able to benefit from the latest treatments.
Each year, about 700,000 people in the United States suffer a stroke, according to the American Stroke Association. It is the third leading cause of death in the country, after heart disease and cancer, claiming 157,000 lives a year.
A stroke occurs when blood flow to the brain is blocked either by a blood clot or the bursting of a blood vessel. This event deprives the brain of oxygen and nutrition, causing the affected part to die. For every second that a stroke goes untreated, 32,000 brain cells die -- nearly 2 million a minute. Depending on the severity of the damage and which part of the brain is affected, a stroke can cause paralysis, vision problems, behavioral changes, speech problems and memory loss.
The good news is that several treatments greatly reduce the damage a stroke can inflict on the human brain. The bad news is that a lot of people don't get to the hospital early enough for therapies to be administered. One therapy, the popular clot buster known as Tissue Plasminogen Activator, or tPA, must be administered within the first three hours for a stroke to be effective.
Should Menstruation Be Optional?
Category: Ortho Evra Warnings
There's an interesting article by Linda A. Johnson, Associated Press that ran Sunday, exploring the trend forwomen to use birth control pills or other hormonal contraceptives to supress monthly periods. One 22-year-old woman interviewed had not experienced a period since she was 17 years old, due to her continuous use of the Nuvaring, a vaginal contraceptive ring. Rather than allowing for menstruation after the third week, she just replaces it with a new ring.
Ortho Evra Lawyers believe in their cause
Category: Ortho Evra Legal News
Whenever someone says, "it's not the money, it's the principle of the thing" we can usually assume it is the money. Unless lawyers are willing to put up the money it takes to pursue litigation, what they say may be little more than just talk. Accordingly, I was heartened to hear that lawyers leading the firght for Ortho Evra victims were willing to put up their own funds to pursue discovery jointly in the Ortho Evra MDL. With leadership from great attorneys like Janet Abaray and Jerry Parker, the efforts of the Plaintiff's lawyers in the MDL in seeking appropriate compensation for victims will certainly be successful. If you are interested in obtaining representation for Ortho Evra related injuries, please contact me.
Johnson and Johnson better than Merck?
Category: Ortho Evra Legal News
Don't be taken in by the drug manufacturers propaganda machine. Here is a link to Merck's new site designed to defend the undefensible in their handling of Vioxx dangers. They provide links to organizations funded by industries that wish to abolish the jury system guaranteed by the constitution. More hooey. Learn the true facts at www.worstpills.org.
Ortho Evra Stroke - Ischemic not Hemmorhaggic
Category: Ortho Evra Medical Information
Many women who may have suffered a stroke wihile on birth control may not know the distinction between a bleeding (hemorhaggic) stroke and a blockage (ischemic) stroke. Strokes from Ortho Evra and other birth control products are normally ischemic (a blood clot stops blood from reaching areas of the brain) and hemorhaggic stroke invole bleeding into the brain and are not generaly caused by birth control. Here is some good information on hemorhaggic strokes:
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.
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