California Vioxx Lawyers - Attorneys Nick Allis and Ray Henke - California Vioxx Attorneys Representing Heart Attack and Stroke Victims in Southern and Northern California. Vioxx Lawyers in Los Angeles the San Francisco Bay Area San Diego Orange County San Jose Oakland and Sacramento.

California Vioxx Lawyers: This is An Informational Website, Providing Information About the Vioxx Recall And Vioxx Clincal Studies Demonstrating Increased Incidence of Heart Attack, Stroke and Other Adverse Reactions. The California Vioxx Lawyers Henke and Allis Will Consider Vioxx Heart Attack and Stroke cases in Northern & Southern California. Obtain a Free Consultation with a California Vioxx Attorney.

California Vioxx lawyers Nicholas Allis and Raymond Henke are your experienced California pharmaceutical product liability attorneys for Vioxx cases involving stroke and heart attack cases. California Vioxx Attorneys Henke and Allis will consider representing Vioxx claimants in Northern and Southern California (Vioxx Lawyers in Los Angeles, the San Francisco Bay Area, San Diego, Orange County and San Jose.) If you suffered myocardial infarction, heart attack, or stroke, while taking Vioxx, the California Vioxx attorneys Allis and Henke would welcome the opportunity to discuss your potential rights of action.

Call Toll Free (877)370-3233 or Submit the California Vioxx Attorney Contact Questionnaire.

Below and on other pages of this site is the California Vioxx Attorneys discuss the Vioxx recall, the Vioxx clinical studies which these attorneys consider significant, the FDA actions with regard to Vioxx, the Vioxx litigation and the information with regard to the mechanism of action of Vioxx as it may explain Vioxx adverse reactions.

California Vioxx Lawyers Credentials, Your California Vioxx Attorneys of Choice.

Summary of Contents of Site Information on the "Vioxx Recall," the Clinical Studies Associating Vioxx with Heart Attack, Stroke and Other Adverse Reactions, and the FDA Vioxx Actions. Also the California Vioxx Attorneys Predictions on Legal Bases for Merck & Company Liability, Punitive Damage Liability and Possible Vioxx Class Action Litigation.

The California Vioxx lawyers Allis and Henke provide additional information below and in the other pages of this web site, about the "Vioxx Recall," referring to the Merck & Company voluntary withdrawal of Vioxx; the California Vioxx lawyers will provide a summary of the clinical studies which implicate Vioxx as associated with an increased incidence of heart attack or myocardial infarction, stroke, transient ischemic attacks (TIA) and other adverse reactions; the California Vioxx lawyers will provide a summary of the significant FDA actions and these California Vioxx lawyers will provide their tentative early predictions of the legal bases and potential bases upon which both liability and potentially punitive damage liability may be established for Merck & Company's marketing of Vioxx. These California Vioxx lawyers will also discuss the Vioxx mechanism of action which may explain the drug's

The "Vioxx Recall." Merck & Company's Withdrawal of Vioxx from the Market

Merck & Company, the manufacturer of Vioxx, voluntarily withdrew Vioxx from the market worldwide on September 30, 2004. In the media the withdrawal has been referred to as the "Vioxx Recall." According to the company's press release, the withdrawal was based upon a placebo controlled study which had to be stopped because the early data demonstrated that those in the Vioxx group had an increased risk for confirmed myocardial events, including heart attacks and stroke, as well as an increased incidence of other cardiovascular disease and adverse reactions. Merck's announcement that it was withdrawing Vioxx, however, also followed substantial earlier evidence including clinical studies (including the March 2000 "VIGOR study")and a peer reviewed published article analyzing the study data (the August 2001 Cleveland Clinic study, published in the Journal of ). This earlier study data demonstrated a four fold increased risk of heart attack, as well as increased incidence of stroke and other cardiovascular disease in association with use of the drug. To learn more about the Vioxx studies which preceded the "Vioxx recall" you may consult the "Vioxx Clinical Studies" page of this web site.

The Vioxx Clinical Studies - Evidence That Vioxx Is Associated with an Increased Incidence of Heart Attack, Stroke and Other Cardiovascular Problems. Evidence Which Vioxx Lawyers Will Use to Establish Merck Liability.

The most important study establishing the increased risk of heart attack in particular as well as stroke and other Vioxx adverse reactions, in these Vioxx attorneys view, is the August 2001 Cleveland Clinic Heart Center study. In these Vioxx lawyers estimation the study also supports the proposition that Merck culpably failed to earlier withdraw the drug and warn consumers in the face of the mounting evidence of the association of Vioxx with an increased incidence of heart attack in particular, stroke, and other adverse health consequences. .The Cleveland Clinic Heart Center study was published in the peer reviewed Journal of the American Medical Association in 2001, based upon data compiled in four previous clinical trials of Vioxx (and Celebrex, a similar drug) involving 18,064 patients. (Vioxx belongs to a category of COX-2 selective, nonsteroidal anti-inflammatory drug [NSAIDS]. Celebrex [celecoxib] is another COX-2 selective NSAID.)

Prior to the publication of the Cleveland study, the data obtained in the March 2000 VIGOR (Vioxx Gastrointestinal Outcomes Research) study also found an increased risk of cardiovascular events in Vioxx users as compared the incidence of cardiovascular events for users of another pain drug. Merck's VIGOR study, comparing Vioxx with naproxen, demonstrated a highly statistically significant five-fold increase in heart attacks in the Vioxx group, 0.5 percent compared to 0.1 percent in the naproxen group. This amounted to 20 heart attacks in the Vioxx users (out of 4,047 patients) compared with four in the naproxen users (out of 4,029 patients). This increased number of heart attacks was also accompanied by an increase in other thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs as well as problems with hypertension in the rofecoxib group compared with the naproxen group.

In September 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Merck to conduct testing specifically to determine whether Vioxx increased the risk of heart attack and stroke. In September, 2002, FDA sent Merck a warning letter asserting that the advertising for Vioxx was misleading. The warning letter was sent to Merck President and CEO Raymond V. Gilmartin, stating:

"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."

Merke subsequently changed its advertising to list "heart attack" in the middle of a dozen infrequent Vioxx "side effects," without mention of the other adverse reactions including stroke, also found to be associated with Vioxx use in the VIGOR and Cleveland studies.
The Merck withdrawal of Vioxx, according to the company's press release in September 2004, was based on adverse data from a new placebo controlled efficacy study to determine whether VIOXX was efficacious in preventing the recurrence of colon polyps.. That study was stopped after the investigators determined that the data demonstrated that human subjects taking Vioxx had an increased risk for confirmed cardiovascular events, including heart attack and stroke over those who were receiving the placebo.

In these Vioxx attorneys view, the Vioxx clinical studies are important evidence to demonstrate that Vioxx users who suffered heart attacks in particular, as well as stroke and the other adverse reactions associated with Vioxx use, may have viable causes of action against Merck and Company. In addition, the evidence suggests that Merck may have deliberately turned a blind eye to the mounting evidence of Vioxx adverse reaction data, failing to respond to the pleas of the American Heart Association and Arthritis Foundation, and falsely advertised Vioxx, as implied also by the FDA warning letter.

Vioxx Litigation - The California Vioxx Attorneys' Perspective On The Most Viable Legal Bases on Which Merck Will be Held Liable For Heart Attack, Stroke and Other Cardiovascular Injuries Caused by Vioxx. The Possible Merits of Vioxx Class Action and Necessary Limitations on Vioxx Class Action. The California Vioxx Attorneys' Analysis of Advisability of Obtaining Independent Vioxx Lawyer Advice Whether Class Action or the Separate Prosecution of Your Individual Litigation Will Best Serve You.

Vioxx lawyers may approach the Vioxx litigation on a number of legal theories or basis provided by the laws of the states in which the injuries occurred, or by state or national class actions asserting various legal bases. There are advantages and disadvantages to each approach a Vioxx attorney may chose in the representation of his client. Furthermore, the evidence, particularly the evidence that will be obtained from discovery, including in-house documents and depositions of the Merck company hierarchy and persons most knowledgeable within the company, including what the company knew and when, and what it decided at each step, will also determine the Vioxx lawyers perspectives on how best to pursue Vioxx litigation by class action and by the separate prosecution of any particular Vioxx claimant's individual litigation.

Based upon the studies demonstrating the association of Vioxx with cardiovascular events and in particular, heart attack and stroke, as well as the September 2001 FDA warning letter asserting that the Merck advertising was false or misleading, perhaps the most obvious legal basis for Merck potential liability arising out of its continued marketing of Vioxx may be "failure to warn" theory. The legal cause of action is composed of legal elements which must be established, however, "failure to warn" theory is essentially what it implies, that the defendant had an obligation to warn of its durgs adverse effects, or based on the information the adverse reactions found to be associated with use of its drug it owed a duty to warn, but nevertheless failed to warn its consumers. There are legal nuances between failure to warn theory in negligence and strict liability across the laws of the states and Vioxx lawyers will frame their causes of action accordingly, however, from a lay informational perspective, this Vioxx attorney would suggest first that "failure to warn" theory generically is perhaps the most obvious theory at least for most Vioxx cases based on the information currently available.

As the evidence continues to develop, in addition to the substantive causes of action, which may also involve intentional torts, it is likely also that claims will be made for punitive damages. Punitive damages are not an element of damages to compensate you for your injuries; rather they are damages in addition to your compensatory damages which may be awarded to punish the defendant pharmaceutical company or to set an example of the pharmaceutical company, generally speaking, for its fraud, malice or oppression. There are variations in the laws of the states, however, one can think of "malice" as approximating a willful and/or conscious disregard of the lives or health of the drug's consumers. One early indication to these California Vioxx lawyers that the evidence would demonstrate Merck's liability for punitive damages was that the concerted Merck Vioxx advertising failed to acknowledge the Vioxx study evidence of Vioxx adverse reactions, in particular cardiovascular incidents, blood clotting, heart attack and stroke, and only changed its advertising to add heart attack as an adverse effect following the FDA's warning letter. Indeed, supportive of these California Vioxx attorneys proposition that Merck may be held liable for punitive damages in many Vioxx cases is the FDA's September 2001 warning letter, inter alia, that Merck's Vioxx advertising was false or misleading.

In the FDA warning letter sent to Merck President and CEO Raymond V. Gilmartin, the FDA stated:

"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."

While Merck added "heart attack" to its list of "infrequent" side effects, it did not add stroke or any of the other adverse reactions found to be linked to Vioxx use by the VIGOR and Cleveland studies. The FDA warning letter does not undercut Merck's obligation to the consumer to warn of all adverse side effects of its drug in addition to heart attack. Merck owes its obligation to warn to the consumer. The fact that the FDA found that the Merck advertising "misrepresented" the safety profile on Vioxx is simply very good initial evidence of Merck's fraud on the Vioxx consumer, to be buttressed by evidence continuing to be developed in discovery in the cases.

Class action may or may not be deemed appropriate for individual Vioxx cases based upon the analysis of counsel in conjunction with the individual client. In some cases class action my serve the individual litigant and in others it may not. In one previous pharmaceutical class action litigation it was attempted by the majority leadership of plaintiff's lead counsel committee in combinations with the pharmaceutical company defendant to fashion a "mandatory class action" and settle the cases of thousands of very seriously injured children alleged to have suffered birth defects as the result of a drug for an total settlement which would have left each individual child with but a few thousand dollars as his or her recovery. The Federal District Court "certified the mandatory class" and approved the settlement. Because the class was certified as a "mandatory class action" the individual plaintiffs were not permitted the opportunity to "opt out" of the class action. Vioxx lawyer, Mr. Henke, for one individual client, filed a "writ of mandamus" a type of appeal, to the Federal Circuit Court, arguing that the mandatory class certification and settlement denied his client his right to the attorney of his choice and control over his individual litigation. Many prominent lawyers from around the country joined in Mr. Henke's petition, and the Court of Appeals accepted the argument set forth in Mr. Henke's petition, voided the class certification and overturned the class settlement. The Court of Appeal held that mandatory class action, as opposed to voluntary class action (where the individual plaintiff may "opt in" or "opt out") can be used only in the very unusual and very restricted circumstance where it can be demonstrated that the defendant has a "limited fund" available to pay the claimants. The lengthy and reasoned opinion of the Court of Appeals upon this Vioxx lawyer's petition for writ of mandamus was published and constitutes a landmark federal judicial opinion defining the legitimate use of class action through this day. In re Bendectin, 749 F.2d 300 (6th Cir. 1985). See, also: R. L. Henke, "Mandatory Class Action," Trial Magazine" the legal journal of the Association of Trial Lawyers of America, May, 1985.

Vioxx attorney, Mr. Henke, has also prosecuted one of the most highly publicized medical drug fraud and punitive damage cases in United States history, arising out of the misrepresentation of the AIDS drug Viroxan, which had been purported by its manufacturer to be beneficial in the treatment of HIV and AIDS. The case was chronicled in legitimate newspapers across the country from a front page article in the New York Times to the front page "Column One" Los Angeles Times, in cover and feature legal and lay magazine articles, and on national television, including Tom Brokaw's NBC Nightly News and CNN. Vioxx lawyer, Mr. Henke, also testified before Congress at the invitation of the Chairman of the House of Representatives Judiciary Committee about the AIDS Medical Drug Fraud cases including specifically his pursuit of punitive damages against the drug's manufacturer and the physicians and hospitals which participated in making the drug available to HIV and AIDS patients. Mr. Henke's experts in the case included Luc Montagnier, the discoverer of HIV and head of France's National AIDS Laboratories, Michael Gotlieb, the discoverer of AIDS and co-founder of the American Foundation for AIDS Research (AMFAR), Don Francis, the wonderful epidemiologist who headed the CDC's first AIDS task force and discovered that AIDS was a sexually transmitted disease and a dozen others of the most highly regarded AIDS scientists in the world. Before the trial Mr. Henke took a writ of mandamus from an adverse trial Court ruling applying new tort reform law which would have denied Mr. Henke's clients their rights to claim punitive damages. The Court of Appeals granted Mr. Henke's petition and ordered the trial court to permit Mr. Henke to proceed with his clients punitive damage claims.. Mr. Henke tried together the cases of 5 of his clients in the first AIDS Drug Medical Fraud trial in the United States, a trial lasting over 4 months, yielding a multimillion dollar jury verdict, including punitive damages against one hospital.. This Vioxx lawyer was recognized by his trial lawyer peers for his work in the Viroxan cases, including his nomination as "Trial Lawyer of the Year" by LATLA.

The broad pharmaceutical product liability experience of Vioxx lawyers nationwide, including Mr. Allis and Mr. Henke, will be important in framing the causes of action and elements of damage, including punitive damages, against Merck, and in determining on a case by case basis whether their individual Vioxx client will be best served by joining in Vioxx class action litigation.

You may consider others of Vioxx lawyer's pharmaceutical product liability attorney qualifications on other pages of this web site. The forgoing discussion of the possible legal theories is not intended as complete by any means but rather a lay explanation of potential directions the Vioxx litigation may lead as further evidence is developed. The limited overview is based upon the education, training and experience of these Vioxx lawyers from their broader experience in pharmaceutical litigation. The information provided above is by no means complete and indeed, as noted, the legal theories asserted by lawyers in the Vioxx litigation will evolve as the discovery in the cases evolves. The discussion above is provided for informational purposes only. It is not legal advice, let alone advice that should be relied upon by a lay person in analyzing whether he may have a viable Vioxx case. For legal advice with regard to your case you must contact a Vioxx lawyer. You may contact Vioxx attorneys Mr. Allis and Mr. Henke for a free case evaluation by calling (877) 370-3233 or by clicking the contact button and submitting the Vioxx case information questionnaire. Please keep in mind that consulting this web site does not create an attorney client relationship with regard to your potential Vioxx case, nor would contacting Mr. Henke or Mr. Allis by telephone or submission of the Vioxx attorney informational questionnaire. Consultations with this Vioxx lawyer are free of charge. An attorney-client relationship with Mr. Henke or Mr. Allis or their firms can only be established by a written contract signed both by the clian and attorney .

Vioxx (Generic: Rofecoxib) is an NSAID Drug, Also Celebrex and Bextra.

Approved by the FDA in 1999 for the treatment of osteoarthritis, menstrual pain and the management of acute pain, Vioxx is the trade name of the generic drug rofecoxib.

Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib).

Vioxx is considered to be effective for its indications by the drug's preventing the formation of inflammatory prostaglandins. Inflammatory prostaglandins are produced by the enzyme "cyclooxygenase 2," sometimes shortened to "Cox-2," which are believed to cause inflammation and pain. They are also considered to prevent blood cells from sticking together. Vioxx is thus known as "Cox-2 inhibitors." Celebrex, the trade name for clelcoxib and Bextra, the trade name for valdecoxib are also "Cox-2 inhibitors." It is not yet known whether the increased risks, including for heart attack and stroke associated with Vioxx are specific to Vioxx. Because of the common mechanism of action, it is possible that like Vioxx, Celebrex and Bextra may also be found to be associated with the same adverse reactions.

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