Our California Ortho Evra Patch Lawyers Offer Free Consultations to Those Who Have Suffered a Heart Attack Stroke Pulmonary Embolism or Other Serious Injury Due to the Ortho Evra Patch. Our Attorneys Will Consider Representing Those Injured By the Ortho Evra Patch in Northern and Southern California, Los Angeles, the San Francisco Bay Area, Berkeley Oakland Santa Clara San Jose Fresno Ventura Orange County, San Diego to Sacramento

Our California Ortho Evra Patch Attorneys of the Henke Law Office are pleased to offer free consultations to all Patch users who have suffered a stroke, heart attack or pulmonary embolism. Please fill out the "California Ortho Evra Patch Lawyers Case Evaluation Request” and our qualified phramaceutical product liability lawyers will call you to discuss the facts of your case, provide our case evaluation, and recommendations. We represent clients injured by the Ortho Evra Patch in Northern and Southern California, in San Francisco and Los Angeles, Orange County San Jose and Oakland, from San Deigo to Sacramento. We will also consider serving as trial counsel in Ortho Evra cases arising in other states where we are contacted by out of state lawyers, with the permission of the our of state court, pro hac vice.

California Ortho Evra Patch attorney Henke is a pharmaceutical product liability lawyer with 20 years experience prosecuting complex pharmaceutical cases against drug manufacturers. Attorney Henke has been involved in most of the major pharmaceutical product litigation of the past 20 years, including the Dalkon Shield, DES, Thalidomide, Bendectin, DPT, and breast implant litigation. Ortho Evra Patch lawyer, Ray Henke is responsible for some of the most important national and California appellate litigation defining the availability and acceptable structure of national pharmaceutical class action litigation; and in undermining California tort reform legislation which would have severely restricted the availability of punitive damages in medical cases.

California Ortho Evra Patch attorney, Ray Henke, was elected and reelected Governor of the Los Angeles Trial Lawyers Association and the Consumer Attorneys Association of Los Angeles, by the large membership of this fifth largest trial lawyer association in the United States. LATLA also nominated Henke “Trial Lawyer of the Year” specifically for his 4 month prosecution of 5 consolidated pharmaceutical test cases to multimillion dollar jury verdict in the first AIDS drug fraud case in America.

California Ortho Evra Patch lawyer, Ray Henke has testified before Congress at the invitation of the Chairman of the Judiciary Committee of the United State House of Representatives, also specifically on the subject of drug litigation and the use of punitive damages to punish the manufacturer and set an example of malicious drug manufacturer misconduct.

Ortho Evra Patch lawyer, Ray Henke and his pharmaceutical cases have been the subject of California and national feature legal journal articles from "California Lawyer" to the National Law Journal. His trial work and successes specifically in pharmaceutical cases have been the subject of scores of feature newspaper articles from the front page of the New York Times to the front page of the Los Angeles Times, from the Washington Post to the San Francisco Examiner and Chronicle, as well as national and international legitimate television news coverage, from Tom Brokaw’s NBC Nightly News to CNN.

California Ortho Evra Patch attorney, Henke, is “AV” rated by Martindale and Hubbell, the highest legal ability and ethical standards ratings awarded by the most respected peer review attorney rating directory in the United States. The Martindale & Hubbell ratings are determined by interviews with judges before whom the lawyer has tried cases and from interviews with other prominent lawyers in the state who are familiary with the attorney's legal ability and ethical standards. The “A” in "AV" is defined as “very high to preeminent” in "legal ability." The “V” is defined as “very high” "general ethical standards." In the words of Martindale Hubbell: “AV peer Review Rating - shows that a lawyer has reached the height of professional excellence. He or she has usually practiced law for many years, and is recognized for the highest levels of skill and integrity.” Henke is also listed as one of the "Top Lawyers in America" and a member of the “Million Dollar Advocates Forum” commonly referred to as the "most prestigious lawyer group in the United States." Mr. Henke has obtained multimillion dollar jury verdicts and settlements specifically in pharmaceutical product liability and drug manufacturer fraud cases, and has been responsible for the most important single published federal Court of Appeals decision governing pharmaceutical product liability mandatory class actions, a decision which guarantees the individual client's choice of counsel and determination over the course of his individual litigation, guaranteeing also the client's right to opt in or out of pharmaceutical class actions.

The Ortho Evra Patch, It’s History, The Evidence of its Association with Increased Incidence of Blood Clots, Stroke, Heart Attack and Death, Ortho-McNiel Misleading Over-promotion, FDA Actions, the New Warnings and the Ortho Evra Lawsuits and Litigation

The Ortho Evra transdermal birth control patch was first approved by the FDA in November 2001 and first introduced in April 2002. The patch was designed to be applied to the skin and release norelgestromin (a progestin hommone) and ethinyl estradiol ( an estrogen homone).through the skin into the blood stream. It was promoted as a contraceptive equally as effective as birth control pills. Because of its convenience and purported safety and effectiveness it soon became the most proscribed type of birth control in the United States.

Prior to FDA approval the Food and Drug Administration was aware from its review of the Ortho-McNiel clinical study data that the patch had an increased incidence of non-fatal blood clots three times greater than the incidence of blood clots in women who used the typical 35 microgram oral contraceptives. The likely explanation is that the patch contains 60 percent more estrogen than the typical 35 milligram birth control pill. The estrogen delivered by the patch to the blood also did not pass through the digestive system. Prior to the FDA approval of the Ortho Evra patch doctors charged with reviewing the data from Ortho-McNiel’s clinical trials warned that the increased incidence of blood clots could present a health risk if the patch was approved. Ortho-McNiel stridently attempted to minimize the risks, including by contending that one of two cases of pulmonary embolism in the clinical studies shouldn’t be counted as an adverse drug event because the woman had recently undergone surgery. But an FDA reviewer, using capital letters for emphasis, took issue with Ortho-McNiel.

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases ...”

The reviewer went on to say: “The incidence rates quoted by the sponsor may be misleading” The reviewer said “The label should clearly reflect this reviewer’s safety concern about a potential increased risk.”

When the Ortho Evra patch was approved by FDA in November 2001, FDA did not require that it warn of the increased risk of blood clots, it didn’t warn of the increased risk, Ortho-McNiel wasn’t required to perform follow-up studies, and FDA didn’t perform a study beyond the routine FDA reviews of adverse reaction reports submitted by consumers and doctors.

Ortho-McNiel instead engaged in an aggressive marketing campaign. Misleading advertisements touting the convenience of the Ortho Evra patch in comparison to oral contraceptives and other means of contraception were aired while the company did little to warn of the risks associated with the patch.

Only in 2004, after an 18 year old New York student died due to a blood clot in her lungs, a pulmonary embolism similar to those which were found in the two clinical test subjects, was another red flag waived that the patch might be responsible for serious health consequences from blood clots, including pulmonary embolism, stroke, heart attack and death.

In the same year a reporter for the Associated Press obtained the FDA's accumulation of 16,000 adverse reaction reports and found that Ortho Evra caused a 300 percent increase in blood clot related incidents, consistent with the three fold increased incidece of blood clots found to be associated with the Ortho Evra patch in the pre-FDA-approval clinical studies.. By November 2005 there were found to bave been 23 deaths associated with use of the Ortho Evra patch. Seventeen of the deaths were directly related to blood clots. Dr. Pamala Barens, an associate professor of obstetrics and gynocology at the University of Texas Medical School at Houson stated: "That number of deaths sounds suspecious. There may be something about the way the drug is metabolized that could increase the risk for clots."

Since the reporting of adverse reactions associated with pharmaceutical use is voluntary, haphazard, generally estimated by the FDA to account for just the tip of the iceberg, between 1 percent and 10 percent of the actual incidence of adverse drug events, the actual number of deaths which have occurred associated with the Ortho Evra patch is probably much higher. And the number of serious adverse incidents of stroke, transient ischemic attacks, heart attack, and pulmonary embolism where the women survived much higher than the number of deaths.

On November 11, 2005 the FDA issued a statement announcing a label chance for the Ortho Evra patch including a new bolded warning about the higher exposure to estrogen for women using the patch compared with those taking 35 microgram oral contraceptives, and that higher levels of estrogen may put some women at increased risk of getting blood clots.

Ortho-McNiel updated its “Safety Information” to read:

“Most side effects of the Patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

“Hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60 percent more estrogen if you use Ortho Evra than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure may increase the risk of side effects. However, it is not known if there are differences in the risk of serious side effects based on the differences between Ortho Evra and a birth control pill containing 35 micrograms of estrogen.”

California Ortho Evra Patch Lawyers Take Issue With Ortho-McNiel’s Position That ‘It is “Not Known” Whether There Is An Increased Likelihood of Blood Clots, Stroke, and Heart Attack in Patch Users Over Users of the Typical Birth Control Pill. The California Ortho Evra Patch Attorneys Are Filing Lawsuits. If You Or A Loved One Has Suffered A Heart Attack, Stroke, Pulmonary Embolism or Clot Associated Death, Contact the Henke Law Firm California Ortho Evra Patch Lawyers For a Free Consultation.

The California Ortho Evra patch lawyers of the Henke Law Office take issue with the response of Otho-McNiel to the mounting evidence of the serious risks of blood clots, pulmonary embolism, stroke and heart attack associated with patch use. From the phrasing of Ortho-McNiel’s obfuscatory and confusing new “safety information” it appears that Ortho-McNiel is going to try to tough it out for as long as it can at the expense of the health and lives of its consumers. The language of the warning, reprinted above, makes it appear that the only increase in incidence of blood clots and blood clot related evens, such as stroke or heart attack, would occur if the patch user smokes cigarrettes. The above language also makes it appear that to the extent that there may be an increased incidence of blood clot related events it would be in women smokers over the age of 35. But the AP review of the FDA adverse reaction reports on the Ortho Evra Patch found a three fold increase in clots and death due to blood clots specifically in women under 35.

Furthermore, the language of the final line of the warning, that “it is not known if there are differences in the risk of side-effects...” is reminiscent of the positions of the tobacco company executives denying for decades that cigarettes cause cancer and are addictive. It is true that well designed prospective, blinded and controlled studies would provide better evidence that the Ortho Evra patch causes an ncreased incidence of blood clots and blood clot related cardiovascular events such as stroke, heart attack and pulmonay embolism. But the combination of (1) the well established causal association between estrogen administration and blood clots; (2) the 60 percent greater estrogen content of the Ortho Evra patch over the typical birth control pill, (3) dose response effect, generally recognized in pharmacology, (4) the more direct means of administration of the estrgen through the skin rather than through the digestive system, (5) the three fold increased incidence of non-leathal clots found in the small clinical trial sample; and (6) the three fold increased incidence of clots, death and other side effects found in AP's analysis of the drug experience reports, all suggest that there is a substantially higher incidence of death and clot related serious cardiovascular events associated with Ortho Evra patch use. For Ortho-McNiel to deny it is disingenuous. Ortho McNiel's position is also ironic given that it is Ortho-McNiel which has failed to perform the prospective or well controlled retrospective studies which would better define its drug's risks. And its continued failure to provide appropriate warnings is irresponsible.

Ortho-McNiel’s liability in the Ortho Evra Patch cases will likely be based upon a number of theories of action, most commonly failure to warn theory. Ortho Evra lawsuits are being filed across the United States. Class actions will likely be filed. One important issue that will likely be faced by individual claimants will be whether to join a class action or prosecute an individual action against the manufacturer. There are potential advantages and disadvantages in class actions, and it is these Orth Evra lawyers opinion that independent legal advice and counsel on the issue, based upon the facts of the individual case and the qualities of the Ortho Evra patch class action litigation as it unfolds will best serve the individual claimants. Attorney Henke is best known among pharmaceutical product liability lawyers for resisting class action, and indeed, is responsible for landmark federal appellate case law restricting the availability of mandatory class action in favor of preserving the individual litigant’s right to counsel of his choice and control over his individual litigation. But Henke considers himself independent, and hence better able to assess the advantages and disadvantages of class action and individual case prosecution for the individual client.

Obtain a California Ortho Evra Patch Lawyers Free Consultation. If You or a Loved One Has Suffered A Stroke, Heart Attack, Pulmonary Embolism, or Clot Related Death While Using the Orho-Evra Patch Submit the California Ortho Evra Patch Attorney Questionnaire And Receive A Free Case Evaluation From Attorney Henke. We Serve Northern and Southern California in Los Angeles, San Francisco, the Bay Area, Berkeley and Oakland, Santa Clara County, San Jose, Sacramento, Fresno, Ventura Orange County and San Diego.

The California Ortho Evra Patch Lawyers of the Henke Law Group are pleased to provide free attorney consultations to those who have suffered serious cardiovascular events including stroke, heart attack or pulmonary embolism while using the Ortho Evra patch. The Ortho Evra Patch Attorneys welcome also the families and loved ones of those who have died from clot related cardiovascular events to Contact us for a free case evaluation. You may contact the Ortho-Evra Patch Lawyers of the Henke Law Firm by submitting the “California Ortho Evra Patch Lawyers Case Evaluation Request” and Mr. Henke will personally call you to discuss your case, provide his initial impressions and recommendations. We serve Southern and Northern California, from San Diego to Sacramento, in Los Angeles and the San Francisco bay area, Orange County Ventura Fresno Santa Clara County San Jose Berkeley and Oakland. Our case consultations are entirely free of charge and without obligation.

Please be aware that statutes of limitation apply to Ortho Evra Patch cases. Statutes of limitation provide the time period within which you must file a complaint in court. If you fail to do so you will be precluded from asserting your legal rights thereafter. Therefore, it is urged that you obtain appropriately qualified pharmaceutical product liability counsel to represent you, and that you do so without delay.