Vioxx Litigation - The Perspective of Pharmaceutical Product Liability Lawyers, Allis and Henke, On The Currently Most Probable Viable Legal Bases on Which Merck Will be Held Liable For Heart Attack, Stroke and Other Injuries Caused by Vioxx. The Possible Merits of Vioxx Class Action and Necessary Limitations on Vioxx Class Action. A Recomendation on the Advisability of Obtaining Independent Vioxx Lawyer Advice Whether Class Action or the Separate Prosecution of Your Individual Litigation Will Best Serve You.

Pharmaceutical product liability lawyers may approach the Vioxx litigation on a number of legal theories provided by the laws of the states in which the injuries occurred, or by state or national class actions. There are advantages and disadvantages to each approach an attorney may chose in the representation of his client. It is the authors' strong opinion that each Vioxx case should be evaluated individually to determine in particular whether class action may serve the particular client or if he or she would be better served by the separate prosecution of his or her individual claim..

The evidence will determine the theories of action upon which the Vioxx litigation will be prosecuted. Already good evidence exists in the Vioxx clinical studies demonstrating the drug's association with an increased incidence of heart attack, stroke, bloot clots and other cardiovascular events. Additional evidence will be developed in "discovery," including in-house Merck documents and from the depositions of the Merck company hierarchy and depositions of the persons most knowledgeable within the company. Of interest will be what Merck knew and when. Of particular interest will be what decisions Merck's officers and directors made and the reasoning of its managing agents which led to the decisions.

Merck tipped its "defense" or at least its "public relations defense" in its press release announcing the Vioxx "voluntary withdrawal." There it attempted to suggest that the increased incidence of heart attack and other adverse reaction associated with Vioxx use was a complete surprise. It asserted that its decision to withdraw Vioxx from the market was the result of the findings of a new Vioxx efficacy study which had to be discontinued because of the increased rate of heart attack and other adverse reactions in the Vioxx group as compared with the plecebo control group.

The press release was misleading. The fact is that previous Vioxx studies demonstrated the same increased incidence of heart attack, stroke, and other adverse cardiovascular events long before September 2004. Indeed, the association was well known since March 2000 (VIGOR Study) replicated in the August 2001 Cleveland Study, published in the peer review Journal of the American Medical Association.

The Merck press release is indeed absurd given that in 2001 the FDA had warned Merck in no uncertain terms that its Vioxx advertising was misleading specifically for its failure to warn of its drug's association with an increased incidence of heart attack as demonstrated in the VIGOR study.

Merck's public relations positioning is untenable, and it will not withstand scrutiny in a courtroom. The likely course of the litigation will be dictated in part by the evidence developed of the full scope of Merck's culpability, and then by the tools traditionally available to pharmaceutical product liability lawyers, the substantive legal theories, possibly punitive damage claims, and then, voluntary class action, which may or may not be advisible for any particular plaintiff.

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, based on the information the adverse reactions found to be associated with use of its drug, and 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 based on the information currently available.

As the evidence develops, in addition to the substantive causes of action, 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 indication to these Vioxx lawyesr that the evidence to be developed may well demonstrate Merck's liability for punitive damages is that its Vioxx advertising failed to acknowledge the clinical study findings of incresed incident of adverse reactions, in particular cardiovascular incidents, heart attack, blood clots and stroke. Merck only changed its advertising to warn of heart attack following the FDA's warning letter. Indeed, supportive of these 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 warnings, 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 owed is obligation to warn to the consumer. Indeed, these authors would suggest that given the substantial increased incidence of these very serious, life threatening adverse reactions, Merck should have withdrawn the drug from the market by Marck 2000.

The fact that the FDA found that the Merck advertising "misrepresented" the safety profile on Vioxx is, however, very good initial evidence of Merck's fraud on the Vioxx consumer, to be buttressed by evidence to be developed in discovery in the cases.

To just touch also on the subject of class action, this form of attempting to resolve "mass disaster" litigation, as it is sometimes referred to generically by the courts, can have substantial potential benefits and substantial potential detriments for the individual pharmaceutical product liability claimant's case. It is the humble but yet strong opinion of the authors, as experienced phramaceutical product liability attorneys that those injured by Vioxx, and those who have lost a family member to Vioxx, should obtain independent legal advice before electing to join a Vioxx class action.

Every Vioxx case should be analyzed on its facts to determine if the client will best be served by joining a class action or prosecuting his or her case separately. In part, for all Vioxx plaintiffs the issue of joining a class action will depend upon the character of the class action as it evolves, the definition of the class, the categories of class claimants, the mechanisms by which the litigation will be processed and the quality of the class action attorneys and their prosecution of the litigation. Generally speaking, class action litigation can often the very best avenue for claimants who have suffered minimal damages and whose actions would be impossible to prosecute economically on an individual basis, e.g., actions for the economic damage associated with the medical monitoring which may be determined to be necessary or indicated for patients who have used Vioxx. On the other hand, for Vioxx users who have suffered substantial physical injury, e.g., stroke or heart attack, it is this Vioxx attorney's opinion that class action might not be suitable or in the best interest of the individual client, depending on the facts of each case.

In previous pharmaceutical litigation it was attempted by the plaintiff's lead counsel committee, in combinations with the pharmaceutical manufacturer to fashion a national "mandatory class action" and settle the cases of many thousands of very seriously injured children alleged to have suffered birth defects as the result of the 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 across the country were not permitted the opportunity to "opt out" of the class action.

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 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, voiding the class certification and overturning the class settlement, holding 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 Mr. Henke'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.

Given the rule of In re. Bendectin, supra, Mr. Henke and Mr. Allis do not believe that Vioxx class counsel will again attempt to bind those who do not want to participate in class litigation. So you should weigh your choice carefully, and obtain independent legal advice before making your election.

If you have (1) a substantial injury case (2) where good evidence exists of causation, such as in the heart attack and stroke cases and cases involving the other adverse reactions shown statistically to be more than doubled in incidence in associating with Vioxx use, and particularly, if there appears to be a reasonable likelyhood of obtaining punitive damages, you should very seriously consider the advantages of separately prosecuting your Vioxx case outside class litigation.

The forgoing discussion of the possible legal theories is not intended as complete by any means but rather a lay explanation of potential directions in which the Vioxx litigation may proceed as further evidence is developed in discovery. 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. 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 respective firms can only be established by a written contract signed both by you and Mr. Allis or Mr. Henke.