Ortho Evra Attorney

Former VP sues Johnson & Johnson over firing

2006-12-29T03:03:51Z

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.

]]> The story explains the case:

New Brunswick, N.J.-based Johnson & Johnson, one of the world's biggest drug and medical product makers, said Friday the ex-executive was fired for inappropriate conduct. In his civil complaint, Dr. Joel S. Lippman alleges he was unlawfully terminated on May 15, after working for Johnson & Johnson for 15 years, because he repeatedly complained about product safety problems and urged several be recalled or not launched. Lippman declined to be interviewed.

The article further details Dr. Lippman's specific concerns about Ortho Evra:

The lawsuit alleges Lippman's problems with his employer began when he complained about inadequate safety data on a hormonal menopausal product called Ortho-Prefest and about serious health concerns over the Ortho Evra patch, "which released dangerously high levels of estrogen into patients."
This September, the Food and Drug Administration required J&J to add a warning to the Ortho Evra package insert stating the risk of dangerous blood clots in the legs and lungs may be higher for women on the patch instead of birth-control pills.

Ortho Evra lawsuits reach 400 in U.S.

2006-11-04T23:16:53Z

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.

]]> This new lawsuit, which is one of 400 of its kind filed in the U.S., claims that 43 women experienced blood clots and other health issues following their use of the Ortho Evra patch.

If you or someone you know has experienced a blood clot, stroke, pulmonary embolism, heart attack or other serious cardiovascular event after using the Ortho Evra birth control patch, it may be in your best interest to conact a personal injury attorney. For a free case evaluation, complete the form at the right of this page.

FDA Updates Ortho Evra Label

2006-10-10T16:28:52Z

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.

]]> A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. There are also high dose estrogen pills on the market, such as the 50 microgram birth control pills, and some women need these. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.

Is the FDA Clarifying It's Position on Preemption?

2006-09-25T17:16:44Z

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)

]]> "To the extent, therefore, that the defendants argue that federal preemption bars any failure-to-warn claim premised on a drug manufacturer's failure to provide a warning not contained in the drug's approved labeling, the defendants are incorrect. FDA has not attempted to 'occupy the field' of prescription drug labeling, and state tort liability for failure to warn does not necessarily prevent FDA from carrying out its regulatory goals. Federal regulations explicitly provide for labeling changes to be made to warn of new hazards or cautions relating to a drug without prior FDA approval. Under this regulatory scheme, preemptive conflict does not exist in every instance in which state tort law seeks to impose liability for the failure to provide a warning not affirmatively mandated by FDA. That said, in some circumstances the imposition of state tort liability on a drug manufacturer for failure to warn would conflict with FDA's regulatory authority or interfere with the accomplishment of federal objectives. Because FDA has not occupied the field, such determinations require an analysis of the agency's actions and the actions that are alleged to give rise to liability. A court must ask whether the warning sought by plaintiff would have rendered the drug misbranded in the agency's judgment at the relevant time, or if any new warnings proposed to be added to the warning label would have been rejected by the agency as unsubstantiated." (p.11) ---

Texas Women Sues Over Patch Injuries

2006-09-14T21:15:38Z

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

2006-09-11T16:12:37Z

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.

]]> Tardive Dyskinesia
In October 2001, after taking Reglan for 14 months, McNeil was hospitalized and diagnosed with EPS and tardive dyskinesia.
McNeil sued Wyeth in Texas state court for failure to warn doctors and consumers of the increased risk of tardive dyskinesia from long-term use of Reglan. After Wyeth removed the case to federal court, the U.S. District Court for the Northern District of Texas granted summary judgment, finding that the label was adequate as a matter of law because it specifically mentioned the symptoms McNeil experienced.
McNeil appealed.
Risk Level Misleading
The Fifth Circuit panel agreed with McNeil that the District Court's reliance on Texas state case law is inapposite to her case. Although Reglan's label mentions the conditions of which McNeil complains, the panel said she does not claim that the warning is inadequate because the conditions are not mentioned but that the label is misleading about the "risk level" for the conditions.
Noting a lack of Texas case law on adequacy of warnings, the panel applied a default Texas rule that questions of adequacy go to a jury. It cited Texas law and the Restatement of Torts, noting that even if there is a learned intermediary, a manufacturer can be liable for an inadequate warning.
"Warning the learned intermediary of a much lower risk than the actual risk could render the warning not just misleading, but ineffective," the panel said. "When the risk described on the label is so low as to induce a doctor to undertake the risk, had he not done so if he were warned of the real risk, we cannot say that no reasonable jury could conclude that a warning was inadequate.
"Thus, if the manufacturer decides to label a risk as 'comparatively rare' and also to provide a numerical quantification of that risk, that number must be within a certain degree of accuracy."
Extended Use Well-Known
The panel rejected Wyeth's argument that it has no duty to warn of risks for use longer than the 12 weeks for which Reglan was approved.
"Wyeth was, or should have been aware that Reglan was prescribed routinely for long-term use," the panel said, citing expert testimony about Wyeth's market data showing long-term use by 84 percent of Reglan users.
"Because the widespread long-term use of Reglan suggests that Wyeth's indication for use for no more than twelve weeks was widely disregarded, a jury could infer that Wyeth's warning was ineffective and thus inadequate," the panel said. "Therefore, McNeil's suggested additional warning about long-term use would not be superfluous."
"Because Wyeth advertised that the risk of developing EPS is 'comparatively rare,' or that it is 0.2% for short term use," the panel said, "just noting that the risk is higher for long-term use may not put a physician on notice that certain studies have found that the risk could be a hundred times higher. That is, because the advertised risk is negligibly low, the mere statement that the risk increases with use does not put a physician on notice that the increase in risk is of a completely different order of magnitude and class of risk.
"Thus, a jury could find that the risk of developing EPS from long-term use was not just higher, but that it was 'significantly' higher, and that the label was therefore misleading and inadequate."
"In sum, because the widespread long-term use of Reglan suggests that Wyeth's indication for use for not more than twelve weeks was widely disregarded, a jury could infer that the warning was ineffective and therefore inadequate," the panel said. "It follows that Wyeth had a duty, under Texas law, [to] adequately warn the learned intermediary of known risks with long term use and not be misleading as to that risk."
Association Vs. Causation
The panel also rejected Wyeth's argument that the mere association of Reglan with a condition does not necessarily show causation that needs to be on the label. The panel noted that Food and Drug Administration regulations require labels to be revised to include warning as soon as there is an association of serious hazards and that a causation relationship need not be proved.
Although Texas law might not require the same warning as the FDA regulation, the panel said state law "does not absolve a manufacturer, as a matter of law, of a duty to warn on grounds that no existing studies or clinical trials prove actual causation."
The panel noted that one of McNeil's experts testified that drug manufacturers frequently change labels based on simple case reports, not actual clinical studies.
"Thus," the panel wrote, "it is not uncommon for drug companies to do precisely what Wyeth claims it cannot do: tell physicians that a certain use is contraindicated even if no clinical or epidemiological studies exist that confirm causation or degree of risk."
Duty Created By Off-Label Use
"Certainly, it is easier for a manufacturer to make an off-label use contraindicated when that use provides only a minimal amount of sales from that drug as opposed to when the off-label use provides the majority of its sales, as allegedly it is with Wyeth and Reglan," the panel said. "But it is precisely this fact - that off-label use allegedly provided a majority of Wyeth's sales - that would create Wyeth's duty to physicians not to be misleading about the risk of long-term use."

Circuit Judge Jerry E. Smith wrote the opinion for Circuit Judges Carolyn Dineen King and Fortunato P. Benavides.

Counsel
Coleman M. Cowan, John A. Jones and George C. Olson of Martin & Jones in Raleigh, N.C., represent McNeil. Michael R. Klatt, Susan E. Burnett and Kelly R. Kimbrough of Clark, Thomas & Winters in Austin, Texas, and Jeffrey R. Pilkington of David, Graham & Stuff in Denver represent Wyeth.

CLients Who Live in a Small Town

2006-09-01T17:10:34Z

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

2006-08-30T20:28:49Z

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

2006-08-17T15:30:16Z

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

2006-08-08T20:50:34Z

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?

2006-07-25T21:14:20Z

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 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.

Should There Be an Ortho Evra Recall?

2006-07-01T15:35:11Z

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?

]]> The families of those who have died while using Ortho Evra want answers. They don't understand why the manufacturer of this drug did not explain that the birth control patch releases up to three times as much estrogen as a regular birth control pill. This amount of estrogen significantly increases the risks of blood clots, which can lead to pulmonary embolisms and death.

In November 2005, the FDA approved an updated label for the Ortho Evra patch, warning doctors and patients of the higher estrogen exposure associated with patch users.

Ortho Evra Blood Clots Continue

2006-06-30T16:02:09Z

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.

]]> Though Ribakusky-Templin had been using Ortho Evra for less than two months, she developed severe and potentially fatal blood clots as a result. Her case is one of dozens reported in the past nine months that have resulted in lawsuits against Ortho-McNeil Pharamceutical Inc., the maker of Ortho Evra.

Many of the women affected by Ortho Evra blood clots have experienced devastating long-term effects, including depression, infertility, and being forced to take blood-thinners for the rest of their lives.

There have also been a number of deaths associated with Ortho Evra use. Heather Scott was an energetic, enthusiastic Indianapolis college student studying radiation therapy, volunteering for the National Heart Association and working full-time. She died suddenly of a pulmonary embolism while using the Ortho Evra birth control patch for nearly a year.

MDL Lawyers Press On

2006-06-29T02:44:13Z

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

2006-06-19T17:42:59Z

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.

]]> The assumed cause of the increased rate of stroke and TIA after halting aspirin is a rebound prothrombotic effect. Experimental studies quoted in the article by Maulaz et al. suggest that this effect can occur 8-21 days after halting aspirin use, and many clinicians feel that withholding aspirin for 5-7 days is risk-free when compared with the low risk of aspirin complicating procedures such as endoscopy or conventional angiography. Most concerning in the present study was the short duration of time that elapsed between the stopping of aspirin and the onset of TIA or stroke-six patients had a stroke within 5 days, and 70% of the strokes occurred in less than 10 days after discontinuation of aspirin. As this is a population-based study analyzing risk, an etiology for the observed strokes can only be surmised. The findings serve as reasonable evidence, however, that interruption of aspirin therapy should be carefully weighed against the risks, and that compliance with aspirin on the patient's part is vital. Other literature supports this view and suggests that continuation of aspirin or the rapid reintroduction of aspirin after coronary artery bypass graft surgery might in fact be beneficial.