A Word from the Defense: Is Defending Vioxx a Recipe for Disaster? Take a Careful Look at Who Is Sounding the Alarm

The message from our plaintiffs' lawyer colleagues has been steady and direct: “Don't bother defending these cases ' you're going to lose and you're going to lose big. Just pay us all lots of money now and save yourself a lot of pain and agony.” And what other message would they send? Their goal is to reap the highest reward from the least amount of effort. Litigating every case on every level; financing and staffing hundreds of complex trials, and waiting for final appellate review of every verdict is no way to run a mass tort practice ' at least not from the plaintiffs' perspective. Given this author's perspective, it makes sense to examine the options more carefully before deciding that the only way to avoid ruin is to wire massive sums into the trial bar's trust accounts.

The thoughts and observations expressed here do not come from someone with any involvement in the Vioxx litigation, and, therefore, are expressed without any particular familiarity with the facts of those individual cases or the relative strengths and weaknesses of the cases being prepared by both sides. These thoughts and observations do come from someone who has spent the last 25 years as an active participant in many of the large pharmaceutical and medical device cases that have preceded the current mass tort du jour. In every instance, with admittedly varying permutations of victory claims from both sides of the battle, the most effective answer to the onslaught of litigation has been a strong and thorough defense '  not only of the conduct and science story, but also of every individual case. Preparing the defense of these cases is never simple or inexpensive, but comprehensive preparation of every aspect of the litigation is the only effective way to overcome the inherent public prejudice and misconceptions of the pharmaceutical industry that the defendant will face as the cases proceed to trial.

These cases consistently erupt from a smattering of lawsuits to a “mass tort” in the same way. There is a revelation ' almost always accompanied by plenty of media attention ' that some drug or medical device is a “killer,” and that the manufacturer, putting “profits before patients,” ignored the “red flags” and continued to market the product to reap “blockbuster” returns. The lay press is always eager to publish the latest expose of purported corporate greed, and the trial bar is happy to supply investigative reporters with running commentary and juicy excerpts culled from the defendants' documents and employee testimony.

Fortunately, in the courtroom, where the rules of evidence will apply, the presentation of the facts will be more balanced. With the increasing prevalence of video depositions, however, the defendants' presentation of the evidence needs to begin at once. No longer are depositions merely “discovery” devices in which it is up to the questioning attorney to ask the right questions and the job of the deponent to answer “only the question asked.” Today, the video depositions are the corporate conduct element of the trial, and the plaintiffs' bar uses these early opportunities to cross-examine the defendants' employees and officers with documents cherry-picked from their files and to create short sound bites that they can play to the jury. To blunt the effect of that tactic, the deposition witnesses must know their documents better than the plaintiffs and must be ready to demonstrate why the generalizations and document excerpts relied on by the plaintiffs do not present the entire picture.

Whether realistic or not, jurors expect company witnesses to know their subject matter with total recall and in finite detail. They expect the witness to be helpful and solicitous to the examining attorney regardless of how hostile the examiner becomes. In addition, witnesses and their counsel must be prepared to present their own “direct” examination as part of the deposition record so that when the jury is presented with the videotape during plaintiff's case, it gets the full story rather than a series of plaintiff's carefully chosen snippets.

Equally important is to develop a thorough and broad understanding of the science. Anyone who has been heavily involved in this type of litigation has learned from the past “disasters” defendants have faced: The general causation story touted by the plaintiffs is never as clear-cut as they claim. The clearest examples of this can be found in the plaintiffs' characterization of the silicone breast implant, Baycol, Rezulin and PPA litigation. When those litigations began, we all heard that each one was even bigger than the last. All of those products were removed from the market with great fanfare. As they do today, the plaintiffs' bar claimed that the science was bulletproof and warned that the only way to avoid ruin was to pay up quickly. Nevertheless, the “science” did not hold up, and now we hear from our colleagues that there are “distinctions” between those other cases and the invincible Vioxx claims.

In each of those prior litigations, the careful development of the science case, along with aggressive challenges to the scientific “evidence” both in the Daubert/Frye context and at trial, demonstrated that plaintiffs' general causation cases were substantially weaker than advertised. In the Breast Implant Litigation, a panel of neutral experts, convened pursuant to Fed. R. Civ. P. 702 by the Multidistrict Litigation judge, conducted evidentiary hearings on the question of whether the plaintiffs' claims that silicone breast implants caused permanent systemic injury were sufficiently reliable to be admitted at trial. In those hearings, and in similar hearings conducted by other courts, the defendants successfully established that there was no scientific basis to those claims. In Baycol and Rezulin, the defendants have successfully shown that the scope of “injuries” claimed by plaintiffs ' and the only way they could justify bringing their thousands of claims ' has no basis in generally recognized science. The Rezulin effort involved challenging at least 15 general causation experts proffered by the plaintiffs. The defendant made numerous motions challenging different theories of claimed injury, and the MDL court held a 2-day evidentiary hearing on the question of whether Rezulin could cause “silent” liver injury. The favorable decisions on those motions will lead to the elimination of thousands of individual Rezulin claims.

An aggressive attack at trial on the plaintiffs' science evidence can even overcome an adverse Daubert ruling. In the PPA litigation, for example, the defendants are faced with an industry-sponsored epidemiology study conducted at Yale University, and nearly all of their Daubert challenges were rejected by the MDL judge. Nevertheless, in eight trials involving nine plaintiffs in which the previously challenged scientific evidence was presented to the jury as proof of causation, there have been seven defense verdicts, a hung jury that was one vote from finding for the defendants, and a single plaintiffs' verdict for $400,000.

Those PPA defense victories highlight what is perhaps the most labor-intensive, but necessary, task in defending pharmaceutical cases ' the case-specific preparation for each individual claim. Regardless of what the plaintiffs can demonstrate on general causation, (ie, whether the product is capable of causing the alleged injury in some people), no plaintiff can recover without proving that the product caused his/her particular injury. As easy as the plaintiffs make this sound, this is their biggest weakness, and specific causation should be the most hotly contested aspect of any case. This causation hurdle is especially difficult when the claimed injury is one that can have as many alternate causes as stroke or cardiac injury.

According to the latest statistics from the American Heart Association, there are about 1,200,000 people who suffer a heart attack each year and 700,000 who suffer strokes. The introduction and withdrawal of Vioxx (as well as all of the other medications claimed to cause cardiac or cerebrovascular injury) had no effect on these statistics. Nearly 34% of the American population suffers from some sort of cardiovascular disease, much of it untreated, and often undiagnosed. The risk factors for heart attack and stroke are numerous and common in our population and include chronic hypertension, tobacco use, diabetes, obesity, abnormal cholesterol levels (elevated LDL or low HDL), and various forms of arterial or vascular disease. There are many factors that affect blood clotting that can make a person prone to stroke including high red blood cell counts and naturally occurring abnormal blood levels of various hormones and enzymes.

Experience has shown that the “previously healthy plaintiff” is, more often than not, a fiction. Diligent investigation needs to include every record available concerning the patient because key data is often found in unexpected places, and, more often than not, the plaintiff has given different medication and medical histories to different doctors. These records are also crucial in establishing the plaintiff's use of relevant medication both before the claimed event and afterward. This investigation of every aspect of a plaintiff's medical history will frequently uncover medical evidence of risk factors and conditions that provide a better and more biologically plausible explanation for the stroke or heart attack than the ingestion of a pain medication. Jurors understand and accept that heart disease is common and that it is a leading cause of death. They also understand that there are many things we can do to avoid the adverse effects of heart disease, but neglect to do so.

So how do the plaintiffs counter the full-court press? They make up for the deficiencies in their cases by filing as many as they can with a view to inundating the defendants and the courts with so much litigation that the only focus is working down the backlog. As they did successfully to asbestos manufacturers, and to Dow Corning in the silicone breast implant litigation, the plaintiffs' bar hopes to inundate the system with enough cases to force the courts to streamline the process, and, as a result, to prevent the defendants from defending each case on its own merits. When Dow Corning could not field enough trial lawyers and witnesses to handle all the breast implant trials that were scheduled to run simultaneously, it resorted to Chapter 11.

Finding thousands of clients to flood the system used to be a difficult process for the plaintiffs, but that is no longer the case. As recently as 10 years ago, collecting hundreds and thousands of cases was a tedious task that relied on print advertising, television commercials and “victims' seminars.” The Internet has changed all that. Just type “Vioxx lawyer” into your search engine and look at the number of lawyers trolling for cases. Some firms have entire departments of clerks and paralegals who do nothing but handle “client intake.” Others rely on feeder firms that advertise for claimants nationally and “refer” cases to the lawyers in the appropriate jurisdiction. It is no surprise, therefore, that the plaintiffs' bar has been able to capitalize on tens of thousands of prospects.

There is unfortunately no quick way out for a pharmaceutical defendant under attack. Given the number of people who took Vioxx at one time or another, and the number of people at risk for heart attack or stroke regardless of what medications they may or may not have taken, any effort now to sit down and negotiate an “endgame” settlement with the brokers of the plaintiffs' bar will only breed more fortune hunters and more cases.

The way to beat these cases is to put together as many teams of top-flight trial lawyers as necessary to prepare every case to be won on summary judgment or tried. Obviously, there will be cases in plaintiff-friendly jurisdictions, and there will be some adverse verdicts, but in the end, no plaintiffs' firm wants to invest repeatedly the million dollars or more it costs to try one of these cases, nor do they want to devote time and resources to trying cases that can easily lead to no recovery at all. In the end, the pharmaceutical defendant will be in a better position to litigate and try large numbers of individual cases, and will have more of an interest in doing so than will the mass-tort plaintiffs' bar, which will be well on its way before long to mining cases for the next mass tort feeding frenzy.

The message from our plaintiffs' lawyer colleagues has been steady and direct: “Don't bother defending these cases ' you're going to lose and you're going to lose big. Just pay us all lots of money now and save yourself a lot of pain and agony.” And what other message would they send? Their goal is to reap the highest reward from the least amount of effort. Litigating every case on every level; financing and staffing hundreds of complex trials, and waiting for final appellate review of every verdict is no way to run a mass tort practice ' at least not from the plaintiffs' perspective. Given this author's perspective, it makes sense to examine the options more carefully before deciding that the only way to avoid ruin is to wire massive sums into the trial bar's trust accounts.

The thoughts and observations expressed here do not come from someone with any involvement in the Vioxx litigation, and, therefore, are expressed without any particular familiarity with the facts of those individual cases or the relative strengths and weaknesses of the cases being prepared by both sides. These thoughts and observations do come from someone who has spent the last 25 years as an active participant in many of the large pharmaceutical and medical device cases that have preceded the current mass tort du jour. In every instance, with admittedly varying permutations of victory claims from both sides of the battle, the most effective answer to the onslaught of litigation has been a strong and thorough defense '  not only of the conduct and science story, but also of every individual case. Preparing the defense of these cases is never simple or inexpensive, but comprehensive preparation of every aspect of the litigation is the only effective way to overcome the inherent public prejudice and misconceptions of the pharmaceutical industry that the defendant will face as the cases proceed to trial.

These cases consistently erupt from a smattering of lawsuits to a “mass tort” in the same way. There is a revelation ' almost always accompanied by plenty of media attention ' that some drug or medical device is a “killer,” and that the manufacturer, putting “profits before patients,” ignored the “red flags” and continued to market the product to reap “blockbuster” returns. The lay press is always eager to publish the latest expose of purported corporate greed, and the trial bar is happy to supply investigative reporters with running commentary and juicy excerpts culled from the defendants' documents and employee testimony.

Fortunately, in the courtroom, where the rules of evidence will apply, the presentation of the facts will be more balanced. With the increasing prevalence of video depositions, however, the defendants' presentation of the evidence needs to begin at once. No longer are depositions merely “discovery” devices in which it is up to the questioning attorney to ask the right questions and the job of the deponent to answer “only the question asked.” Today, the video depositions are the corporate conduct element of the trial, and the plaintiffs' bar uses these early opportunities to cross-examine the defendants' employees and officers with documents cherry-picked from their files and to create short sound bites that they can play to the jury. To blunt the effect of that tactic, the deposition witnesses must know their documents better than the plaintiffs and must be ready to demonstrate why the generalizations and document excerpts relied on by the plaintiffs do not present the entire picture.

Whether realistic or not, jurors expect company witnesses to know their subject matter with total recall and in finite detail. They expect the witness to be helpful and solicitous to the examining attorney regardless of how hostile the examiner becomes. In addition, witnesses and their counsel must be prepared to present their own “direct” examination as part of the deposition record so that when the jury is presented with the videotape during plaintiff's case, it gets the full story rather than a series of plaintiff's carefully chosen snippets.

Equally important is to develop a thorough and broad understanding of the science. Anyone who has been heavily involved in this type of litigation has learned from the past “disasters” defendants have faced: The general causation story touted by the plaintiffs is never as clear-cut as they claim. The clearest examples of this can be found in the plaintiffs' characterization of the silicone breast implant, Baycol, Rezulin and PPA litigation. When those litigations began, we all heard that each one was even bigger than the last. All of those products were removed from the market with great fanfare. As they do today, the plaintiffs' bar claimed that the science was bulletproof and warned that the only way to avoid ruin was to pay up quickly. Nevertheless, the “science” did not hold up, and now we hear from our colleagues that there are “distinctions” between those other cases and the invincible Vioxx claims.

In each of those prior litigations, the careful development of the science case, along with aggressive challenges to the scientific “evidence” both in the Daubert/Frye context and at trial, demonstrated that plaintiffs' general causation cases were substantially weaker than advertised. In the Breast Implant Litigation, a panel of neutral experts, convened pursuant to Fed. R. Civ. P. 702 by the Multidistrict Litigation judge, conducted evidentiary hearings on the question of whether the plaintiffs' claims that silicone breast implants caused permanent systemic injury were sufficiently reliable to be admitted at trial. In those hearings, and in similar hearings conducted by other courts, the defendants successfully established that there was no scientific basis to those claims. In Baycol and Rezulin, the defendants have successfully shown that the scope of “injuries” claimed by plaintiffs ' and the only way they could justify bringing their thousands of claims ' has no basis in generally recognized science. The Rezulin effort involved challenging at least 15 general causation experts proffered by the plaintiffs. The defendant made numerous motions challenging different theories of claimed injury, and the MDL court held a 2-day evidentiary hearing on the question of whether Rezulin could cause “silent” liver injury. The favorable decisions on those motions will lead to the elimination of thousands of individual Rezulin claims.

An aggressive attack at trial on the plaintiffs' science evidence can even overcome an adverse Daubert ruling. In the PPA litigation, for example, the defendants are faced with an industry-sponsored epidemiology study conducted at Yale University, and nearly all of their Daubert challenges were rejected by the MDL judge. Nevertheless, in eight trials involving nine plaintiffs in which the previously challenged scientific evidence was presented to the jury as proof of causation, there have been seven defense verdicts, a hung jury that was one vote from finding for the defendants, and a single plaintiffs' verdict for $400,000.

Those PPA defense victories highlight what is perhaps the most labor-intensive, but necessary, task in defending pharmaceutical cases ' the case-specific preparation for each individual claim. Regardless of what the plaintiffs can demonstrate on general causation, (ie, whether the product is capable of causing the alleged injury in some people), no plaintiff can recover without proving that the product caused his/her particular injury. As easy as the plaintiffs make this sound, this is their biggest weakness, and specific causation should be the most hotly contested aspect of any case. This causation hurdle is especially difficult when the claimed injury is one that can have as many alternate causes as stroke or cardiac injury.

According to the latest statistics from the American Heart Association, there are about 1,200,000 people who suffer a heart attack each year and 700,000 who suffer strokes. The introduction and withdrawal of Vioxx (as well as all of the other medications claimed to cause cardiac or cerebrovascular injury) had no effect on these statistics. Nearly 34% of the American population suffers from some sort of cardiovascular disease, much of it untreated, and often undiagnosed. The risk factors for heart attack and stroke are numerous and common in our population and include chronic hypertension, tobacco use, diabetes, obesity, abnormal cholesterol levels (elevated LDL or low HDL), and various forms of arterial or vascular disease. There are many factors that affect blood clotting that can make a person prone to stroke including high red blood cell counts and naturally occurring abnormal blood levels of various hormones and enzymes.

Experience has shown that the “previously healthy plaintiff” is, more often than not, a fiction. Diligent investigation needs to include every record available concerning the patient because key data is often found in unexpected places, and, more often than not, the plaintiff has given different medication and medical histories to different doctors. These records are also crucial in establishing the plaintiff's use of relevant medication both before the claimed event and afterward. This investigation of every aspect of a plaintiff's medical history will frequently uncover medical evidence of risk factors and conditions that provide a better and more biologically plausible explanation for the stroke or heart attack than the ingestion of a pain medication. Jurors understand and accept that heart disease is common and that it is a leading cause of death. They also understand that there are many things we can do to avoid the adverse effects of heart disease, but neglect to do so.

So how do the plaintiffs counter the full-court press? They make up for the deficiencies in their cases by filing as many as they can with a view to inundating the defendants and the courts with so much litigation that the only focus is working down the backlog. As they did successfully to asbestos manufacturers, and to Dow Corning in the silicone breast implant litigation, the plaintiffs' bar hopes to inundate the system with enough cases to force the courts to streamline the process, and, as a result, to prevent the defendants from defending each case on its own merits. When Dow Corning could not field enough trial lawyers and witnesses to handle all the breast implant trials that were scheduled to run simultaneously, it resorted to Chapter 11.

Finding thousands of clients to flood the system used to be a difficult process for the plaintiffs, but that is no longer the case. As recently as 10 years ago, collecting hundreds and thousands of cases was a tedious task that relied on print advertising, television commercials and “victims' seminars.” The Internet has changed all that. Just type “Vioxx lawyer” into your search engine and look at the number of lawyers trolling for cases. Some firms have entire departments of clerks and paralegals who do nothing but handle “client intake.” Others rely on feeder firms that advertise for claimants nationally and “refer” cases to the lawyers in the appropriate jurisdiction. It is no surprise, therefore, that the plaintiffs' bar has been able to capitalize on tens of thousands of prospects.

There is unfortunately no quick way out for a pharmaceutical defendant under attack. Given the number of people who took Vioxx at one time or another, and the number of people at risk for heart attack or stroke regardless of what medications they may or may not have taken, any effort now to sit down and negotiate an “endgame” settlement with the brokers of the plaintiffs' bar will only breed more fortune hunters and more cases.

The way to beat these cases is to put together as many teams of top-flight trial lawyers as necessary to prepare every case to be won on summary judgment or tried. Obviously, there will be cases in plaintiff-friendly jurisdictions, and there will be some adverse verdicts, but in the end, no plaintiffs' firm wants to invest repeatedly the million dollars or more it costs to try one of these cases, nor do they want to devote time and resources to trying cases that can easily lead to no recovery at all. In the end, the pharmaceutical defendant will be in a better position to litigate and try large numbers of individual cases, and will have more of an interest in doing so than will the mass-tort plaintiffs' bar, which will be well on its way before long to mining cases for the next mass tort feeding frenzy.