Lessons from the First Vioxx Verdict

What do you get when you cross Court TV with the Food Channel? One answer: a recipe for a multi-million dollar jury verdict! Drug giant Merck will not see such blended TV programming, but it may have seen stars after getting hit with a $253 million jury award on Aug. 19, 2005. The first product liability trial against its Cox-2 inhibitor drug Vioxx in Angleton, TX, in August, 2005 produced a quarter-billion dollar award, $229 million of which was for punitive damages. Merck plans a vigorous appeal on multiple grounds. (Reportedly, grounds for appeal include: 1) letting in testimony from unqualified experts; 2) letting in testimony not based on reliable scientific evidence; 3) allowing irrelevant but prejudicial evidence in against Merck; and 4) letting in an undisclosed “surprise” witness against Merck.) Even pro-plaintiff observers concede that the award will likely drop to “only” $26 million due to recent Texas tort reform caps on punitive damages. (Merck fared better in its second and third Vioxx trials, which ended with a defense verdict and hung jury, respectively. Three Vioxx cases down — only about 5998 to go!)

What are the lessons here for doctors and hospitals? What are the implications for defending medical malpractice cases that we can extract from Merck's Vioxx experience? Can we post-mortem the Vioxx trial in Texas to glean kernels of wisdom that will help doctors and hospitals better defend themselves? How can doctors and legal counsel defending them avoid the same fate?

What We Can Learn

Let us first resist any temptation to “pile on” Merck for losing the case. Hindsight is 20/20 and it is now easy in retrospect to second-guess Merck's defense strategy. Nevertheless, this should not blind us to the event's implications for physicians, hospitals and other medical professionals who face liability claims. Indeed, the first Vioxx trial offers instructive lessons for doctors and medical care professionals who grapple with liability issues.

To avoid a runaway jury award on medical malpractice claims, here are tips and lessons from the first Vioxx trial:

Think Twice Before Hiring 'Big Gun' Out-of-Town Law Firms

This doesn't fly in Small Town USA. From the start, Merck embraced a strategy of foregoing settlement and trying Vioxx cases. It lined up the best and brightest — Washington, DC's Williams & Connolly, Houston's Fulbright & Jaworski and New York City's Hughes Hubbard & Reed. These are superb and large defense law firms, but they may not have “played” well to a Brazoria County, TX, jury. Post-verdict interviews quoted some jurors saying they tuned out the defense team altogether.

Doctors may think that having a “big name” firm will scare off the other side. It rarely works this way in the rough and tumble of civil lawsuits, though. If anything, the plaintiff may assume that he or she has a big case, or else why would the medical practitioner have gone to the trouble (and expense) of retaining such a big name firm?

Do Not Bank on the Deterrence Theory!

Merck viewed its first Vioxx case, among all its Vioxx cases, as winnable. Merck felt that science was on its side (and maybe it was). The plaintiff in that case died of cardiac arrhythmia — not a heart attack and not a stroke — and no solid scientific evidence has linked Vioxx to cardiac arrhythmia. The plaintiff had only been on Vioxx for 8 months, whereas Merck's research showed only that patients using Vioxx for over 18 months had a heightened risk of heart attacks and strokes.

Reportedly, Merck hand-picked this claim as a test case to gauge its national strategy to try each case individually. The deterrence theory – the notion that trying cases discourages other claims — has surface appeal, but is often a pipe dream. Merck lost in Angleton, TX, and now thousands of additional plaintiffs across the globe are filing claims. (Now that Merck has won trial number two in New Jersey, the deterrence effect would suggest that other claims will just go away — not a very likely scenario.)

Doctors thinking that taking a case to trial will deter other patients from suing them are apt to be disillusioned. First, this only has a chance of working if the doctor wins. Second, other patients or attorneys down the line will dismiss an earlier defense verdict as being due to dissimilarities between their case and the earlier one.

Do Not Count Too Heavily on Scientific/Medical/Technical Testimony

Merck was convinced that the outcome of an analysis of causation would be on its side. No good studies showed that Vioxx caused fatal cardiac arrhythmias. The drug maker's confidence was, however, misplaced. Similarly, physician defendants are often frustrated when forced to deal with liability clams where science and medicine are clearly not on the plaintiff's side. Where is the justice in a legal system that allows a physician to be accused, and forces him or her to incur significant expense on the basis of such flimsy support?

Merck's problem in its first Vioxx trial — as it is for many defendant doctors — was that its experts were too scientific and did not speak to jurors on a layperson's level. Legal defenses relying on technical medical and scientific experts often cause jurors' eyes to glaze over, causing the whole defense to go right over their heads. Referring to Merck's scientific and medical defenses, one juror reportedly said after trial, “We didn't know what the heck they [Merck's lawyers] were talking about.” “The Vioxx Hex,” The Washington Post, 9/16/05, p. A30. As one letter to the The Wall Street Journal stated shortly after the verdict, “Why our society entrusts its most complex scientific disputes to 12 people who are scientifically ignorant is so utterly illogical that no one could possibly defend it in a court of reason.” “Verdicts Indefensible in Court of Reason.” The Wall Street Journal, 9/9/05, p. A17.

What pharmaceutical product liability suits have in common with medical malpractice cases is that the defense of both often hinges on communicating fine-line scientific and medical arguments that may be hard for lay jurors to follow. Contrasted with these technical arguments is the vivid presence of an injured patient or aggrieved family. In both cases, it is tempting for jurors to reason that something likely went wrong, even if the proof is murky and, anyway, the big drug company or doctor has the financial wherewithal to make things right. The injured patient shouldn't be left holding the bag.

Do Not Videotape Your Top Honchos or Avoid Live Testimony

Merck's CEO and other corporate reps did not testify live at the Angleton, TX, trial. They spoke to the jury only by video. This may have rankled some jurors. One juror said, “The big guys didn't show up — that didn't sit well with me. Most definitely an admission of guilt.” Not good!

Doctors are time-pressed individuals who are spread thin. Time spent in courtrooms is clearly time that cannot be spent with patients or practicing medicine. As a result, doctor defendants may resist the notion that they should attend the entire trial or sit with legal counsel at the defense table. However, this is a dangerous idea if one wants to maximize the odds of winning a medical malpractice case. As that great philosopher Woody Allen once stated, “Ninety percent of success in life comes from just showing up.” If a case goes to trial, make sure the accused medical practitioner shows up. Make sure he or she is visible. There are times when a token appearance or a videotape just won't do. Defense of a medical malpractice trial is one of those situations. Absence from the trial at any point may be misinterpreted by jurors as an uncaring or arrogant attitude on the doctor's part.

Do Not Discount the Jury Impact of Bad Documents

The first Vioxx trial included disclosure to the jury of troublesome internal documents (eg, e-mails). For example, a sales training program for fielding doctor questions was termed “Dodgeball.” The top company scientist wrote of the possibility of increased cardiovascular events, showing jurors that there were sizable concerns 2 years before Vioxx hit the market. Lessons abound here for physicians who find themselves named in a medical malpractice suit. Omissions in a medical chart or after-the-fact “additions” to the medical record will torpedo the best defense of a medical malpractice case. Disclosing either to a jury can be inflammatory and suggest a cover-up of medical negligence. In a case involving bad documents, give extra consideration to settling the case.

Do Not Cut Investigative Corners, Especially in Precedent-Setting Cases

Apparently, in the first Vioxx trial, Merck's defense team opted not to track down the coroner who performed the autopsy on the deceased. The plaintiff's team went out of its way to do this, spent the extra money, interviewed her and then flew her in from Abu Dubai to testify live at trial. This investment paid off for the plaintiff. While the coroner's cause of death diagnosis was cardiac arrhythmia secondary to coronary atherosclerosis (hardening of arteries, which is years in the making), she could not rule out a causal connection to Vioxx.

Go the extra mile. Monitor what your malpractice insurer is doing (and not doing) so that all bases are covered in investigating your claim, lining up the best expert witnesses and turning over every stone. Insurers are cost-conscious — some to a fault. Be a vigilant policyholder to make sure that the insurer is not cutting any investigative corners at your expense in its zeal to save money in case defense.

Seek Independent Feedback During Trial

During Merck's first Vioxx trial, the plaintiff's lawyer used a shadow jury; a group of laypeople who as closely as possible mirrored the local jury pool. They sat as observers during trial and gave periodic feedback to the attorneys about what was working and what was not.

Many experts feel that in high stakes litigation such as the Vioxx trials, a shadow jury can help fine-tune trial tactics, gauge strategy and make mid-course adjustments. Plaintiff counsel's shadow jury convened daily and was debriefed by a jury consultant. In turn, the jury consultant told plaintiff counsel what was working and what was not. Mostly, the feedback was that the plaintiff's approach was clicking with the jury. The consultant urged the attorney to drive home the theme that this jury had the world's attention and the world would want to hear from them. He did so, the jury responded, and the world heard. Had the defense availed itself of a shadow jury, maybe it could have made mid-course corrections in trial preparation or tweaked its resolution strategy.

Do Not Read to Jurors

Reportedly, Merck's defense case's opening in the Texas case was read by David Kiernan (a Williams & Connolly partner). It sounded clinical and may have turned off jurors. Read aloud to kindergartners, not to jurors in lawsuits!

Humanize the Doctor and the Defense Theme

The plaintiff attorney in the Texas Vioxx case — a part-time local Baptist minister — made the first case human by making the lawsuit about the plaintiff, not the science. He appealed to jurors' empathetic feelings of loss, outrage and retribution. Without notes, he presented his opening statement with about 80 Power Point slides, but he maintained eye contact with jurors. It worked.

Invest in Audiovisuals

The plaintiff's attorney hired a PowerPoint expert to create slides for the first Vioxx trial. This included images like Merck's name alongside three walnut shells, with the caption, “Merck Duped the FDA.” There were also pictures of plaintiff Robert Ernst finishing a marathon, with the caption, “Picture of Health.” This apparently helped sell the theme to the jury. Physician defendants in medical malpractice cases should consider this approach.

'Play Nice'

Reportedly in trial number one, Merck's defense team cross-examined the grieving widow for 90 minutes. By some accounts, it was painful to watch. This may have evoked sympathy among jurors for the plaintiff, and provoked hostility toward Merck, perceived as a corporate bully. Playing hardball with sympathetic witnesses can backfire against aggressive defendants, whether that defendant is a big pharmaceutical company or a local physician or hospital. Such tactics may produce inflammatory awards for punitive damages as well.

Do Not Confuse Boardroom Reality with Courtroom Reality

Defense attorneys and physicians sitting around conference tables can easily convince themselves that they are good people, meant no harm and deserve the benefit of the doubt. Further, the claim before them has weak causation. Ergo, the claim lacks merit and should be tried. It matters not, though, what a bunch of suits (or white coats) sitting around a meeting room think. It matters a great deal what a group of lay jurors will think and how they will view a defendant's conduct. If the O.J. Simpson and Michael Jackson trials teach us anything, it is that there is courtroom reality and then there is … reality. What matters is what a skilled attorney can “sell” to a jury of lay people.

Conclusion

Do not think that jumbo awards can only happen to big companies. Do not think that they only happen to trials in Texas. Do not think that it couldn't happen to you. Physicians and hospitals facing professional liability exposures can and should learn from Merck's experience in the first Vioxx trial. They can avoid the risk management and claim headaches that flow from a blockbuster award. Your client's medical practice or institution wants blockbuster medical breakthroughs, happy patients and financial solvency — not blockbuster headlines or jury awards. Read and heed the lessons of Merck's first Vioxx trial and give those clients what they want!

Kevin M. Quinley, a member of this newsletter's Board of Editors, is Senior Vice President of Medmarc Insurance Group, Chantilly, VA. He can be reached at [email protected] or at his Web site, www.kevinquinley.com.

What do you get when you cross Court TV with the Food Channel? One answer: a recipe for a multi-million dollar jury verdict! Drug giant Merck will not see such blended TV programming, but it may have seen stars after getting hit with a $253 million jury award on Aug. 19, 2005. The first product liability trial against its Cox-2 inhibitor drug Vioxx in Angleton, TX, in August, 2005 produced a quarter-billion dollar award, $229 million of which was for punitive damages. Merck plans a vigorous appeal on multiple grounds. (Reportedly, grounds for appeal include: 1) letting in testimony from unqualified experts; 2) letting in testimony not based on reliable scientific evidence; 3) allowing irrelevant but prejudicial evidence in against Merck; and 4) letting in an undisclosed “surprise” witness against Merck.) Even pro-plaintiff observers concede that the award will likely drop to “only” $26 million due to recent Texas tort reform caps on punitive damages. (Merck fared better in its second and third Vioxx trials, which ended with a defense verdict and hung jury, respectively. Three Vioxx cases down — only about 5998 to go!)

What are the lessons here for doctors and hospitals? What are the implications for defending medical malpractice cases that we can extract from Merck's Vioxx experience? Can we post-mortem the Vioxx trial in Texas to glean kernels of wisdom that will help doctors and hospitals better defend themselves? How can doctors and legal counsel defending them avoid the same fate?

What We Can Learn

Let us first resist any temptation to “pile on” Merck for losing the case. Hindsight is 20/20 and it is now easy in retrospect to second-guess Merck's defense strategy. Nevertheless, this should not blind us to the event's implications for physicians, hospitals and other medical professionals who face liability claims. Indeed, the first Vioxx trial offers instructive lessons for doctors and medical care professionals who grapple with liability issues.

To avoid a runaway jury award on medical malpractice claims, here are tips and lessons from the first Vioxx trial:

Think Twice Before Hiring 'Big Gun' Out-of-Town Law Firms

This doesn't fly in Small Town USA. From the start, Merck embraced a strategy of foregoing settlement and trying Vioxx cases. It lined up the best and brightest — Washington, DC's Williams & Connolly, Houston's Fulbright & Jaworski and New York City's Hughes Hubbard & Reed. These are superb and large defense law firms, but they may not have “played” well to a Brazoria County, TX, jury. Post-verdict interviews quoted some jurors saying they tuned out the defense team altogether.

Doctors may think that having a “big name” firm will scare off the other side. It rarely works this way in the rough and tumble of civil lawsuits, though. If anything, the plaintiff may assume that he or she has a big case, or else why would the medical practitioner have gone to the trouble (and expense) of retaining such a big name firm?

Do Not Bank on the Deterrence Theory!

Merck viewed its first Vioxx case, among all its Vioxx cases, as winnable. Merck felt that science was on its side (and maybe it was). The plaintiff in that case died of cardiac arrhythmia — not a heart attack and not a stroke — and no solid scientific evidence has linked Vioxx to cardiac arrhythmia. The plaintiff had only been on Vioxx for 8 months, whereas Merck's research showed only that patients using Vioxx for over 18 months had a heightened risk of heart attacks and strokes.

Reportedly, Merck hand-picked this claim as a test case to gauge its national strategy to try each case individually. The deterrence theory – the notion that trying cases discourages other claims — has surface appeal, but is often a pipe dream. Merck lost in Angleton, TX, and now thousands of additional plaintiffs across the globe are filing claims. (Now that Merck has won trial number two in New Jersey, the deterrence effect would suggest that other claims will just go away — not a very likely scenario.)

Doctors thinking that taking a case to trial will deter other patients from suing them are apt to be disillusioned. First, this only has a chance of working if the doctor wins. Second, other patients or attorneys down the line will dismiss an earlier defense verdict as being due to dissimilarities between their case and the earlier one.

Do Not Count Too Heavily on Scientific/Medical/Technical Testimony

Merck was convinced that the outcome of an analysis of causation would be on its side. No good studies showed that Vioxx caused fatal cardiac arrhythmias. The drug maker's confidence was, however, misplaced. Similarly, physician defendants are often frustrated when forced to deal with liability clams where science and medicine are clearly not on the plaintiff's side. Where is the justice in a legal system that allows a physician to be accused, and forces him or her to incur significant expense on the basis of such flimsy support?

Merck's problem in its first Vioxx trial — as it is for many defendant doctors — was that its experts were too scientific and did not speak to jurors on a layperson's level. Legal defenses relying on technical medical and scientific experts often cause jurors' eyes to glaze over, causing the whole defense to go right over their heads. Referring to Merck's scientific and medical defenses, one juror reportedly said after trial, “We didn't know what the heck they [Merck's lawyers] were talking about.” “The Vioxx Hex,” The Washington Post, 9/16/05, p. A30. As one letter to the The Wall Street Journal stated shortly after the verdict, “Why our society entrusts its most complex scientific disputes to 12 people who are scientifically ignorant is so utterly illogical that no one could possibly defend it in a court of reason.” “Verdicts Indefensible in Court of Reason.” The Wall Street Journal, 9/9/05, p. A17.

What pharmaceutical product liability suits have in common with medical malpractice cases is that the defense of both often hinges on communicating fine-line scientific and medical arguments that may be hard for lay jurors to follow. Contrasted with these technical arguments is the vivid presence of an injured patient or aggrieved family. In both cases, it is tempting for jurors to reason that something likely went wrong, even if the proof is murky and, anyway, the big drug company or doctor has the financial wherewithal to make things right. The injured patient shouldn't be left holding the bag.

Do Not Videotape Your Top Honchos or Avoid Live Testimony

Merck's CEO and other corporate reps did not testify live at the Angleton, TX, trial. They spoke to the jury only by video. This may have rankled some jurors. One juror said, “The big guys didn't show up — that didn't sit well with me. Most definitely an admission of guilt.” Not good!

Doctors are time-pressed individuals who are spread thin. Time spent in courtrooms is clearly time that cannot be spent with patients or practicing medicine. As a result, doctor defendants may resist the notion that they should attend the entire trial or sit with legal counsel at the defense table. However, this is a dangerous idea if one wants to maximize the odds of winning a medical malpractice case. As that great philosopher Woody Allen once stated, “Ninety percent of success in life comes from just showing up.” If a case goes to trial, make sure the accused medical practitioner shows up. Make sure he or she is visible. There are times when a token appearance or a videotape just won't do. Defense of a medical malpractice trial is one of those situations. Absence from the trial at any point may be misinterpreted by jurors as an uncaring or arrogant attitude on the doctor's part.

Do Not Discount the Jury Impact of Bad Documents

The first Vioxx trial included disclosure to the jury of troublesome internal documents (eg, e-mails). For example, a sales training program for fielding doctor questions was termed “Dodgeball.” The top company scientist wrote of the possibility of increased cardiovascular events, showing jurors that there were sizable concerns 2 years before Vioxx hit the market. Lessons abound here for physicians who find themselves named in a medical malpractice suit. Omissions in a medical chart or after-the-fact “additions” to the medical record will torpedo the best defense of a medical malpractice case. Disclosing either to a jury can be inflammatory and suggest a cover-up of medical negligence. In a case involving bad documents, give extra consideration to settling the case.

Do Not Cut Investigative Corners, Especially in Precedent-Setting Cases

Apparently, in the first Vioxx trial, Merck's defense team opted not to track down the coroner who performed the autopsy on the deceased. The plaintiff's team went out of its way to do this, spent the extra money, interviewed her and then flew her in from Abu Dubai to testify live at trial. This investment paid off for the plaintiff. While the coroner's cause of death diagnosis was cardiac arrhythmia secondary to coronary atherosclerosis (hardening of arteries, which is years in the making), she could not rule out a causal connection to Vioxx.

Go the extra mile. Monitor what your malpractice insurer is doing (and not doing) so that all bases are covered in investigating your claim, lining up the best expert witnesses and turning over every stone. Insurers are cost-conscious — some to a fault. Be a vigilant policyholder to make sure that the insurer is not cutting any investigative corners at your expense in its zeal to save money in case defense.

Seek Independent Feedback During Trial

During Merck's first Vioxx trial, the plaintiff's lawyer used a shadow jury; a group of laypeople who as closely as possible mirrored the local jury pool. They sat as observers during trial and gave periodic feedback to the attorneys about what was working and what was not.

Many experts feel that in high stakes litigation such as the Vioxx trials, a shadow jury can help fine-tune trial tactics, gauge strategy and make mid-course adjustments. Plaintiff counsel's shadow jury convened daily and was debriefed by a jury consultant. In turn, the jury consultant told plaintiff counsel what was working and what was not. Mostly, the feedback was that the plaintiff's approach was clicking with the jury. The consultant urged the attorney to drive home the theme that this jury had the world's attention and the world would want to hear from them. He did so, the jury responded, and the world heard. Had the defense availed itself of a shadow jury, maybe it could have made mid-course corrections in trial preparation or tweaked its resolution strategy.

Do Not Read to Jurors

Reportedly, Merck's defense case's opening in the Texas case was read by David Kiernan (a Williams & Connolly partner). It sounded clinical and may have turned off jurors. Read aloud to kindergartners, not to jurors in lawsuits!

Humanize the Doctor and the Defense Theme

The plaintiff attorney in the Texas Vioxx case — a part-time local Baptist minister — made the first case human by making the lawsuit about the plaintiff, not the science. He appealed to jurors' empathetic feelings of loss, outrage and retribution. Without notes, he presented his opening statement with about 80 Power Point slides, but he maintained eye contact with jurors. It worked.

Invest in Audiovisuals

The plaintiff's attorney hired a PowerPoint expert to create slides for the first Vioxx trial. This included images like Merck's name alongside three walnut shells, with the caption, “Merck Duped the FDA.” There were also pictures of plaintiff Robert Ernst finishing a marathon, with the caption, “Picture of Health.” This apparently helped sell the theme to the jury. Physician defendants in medical malpractice cases should consider this approach.

'Play Nice'

Reportedly in trial number one, Merck's defense team cross-examined the grieving widow for 90 minutes. By some accounts, it was painful to watch. This may have evoked sympathy among jurors for the plaintiff, and provoked hostility toward Merck, perceived as a corporate bully. Playing hardball with sympathetic witnesses can backfire against aggressive defendants, whether that defendant is a big pharmaceutical company or a local physician or hospital. Such tactics may produce inflammatory awards for punitive damages as well.

Do Not Confuse Boardroom Reality with Courtroom Reality

Defense attorneys and physicians sitting around conference tables can easily convince themselves that they are good people, meant no harm and deserve the benefit of the doubt. Further, the claim before them has weak causation. Ergo, the claim lacks merit and should be tried. It matters not, though, what a bunch of suits (or white coats) sitting around a meeting room think. It matters a great deal what a group of lay jurors will think and how they will view a defendant's conduct. If the O.J. Simpson and Michael Jackson trials teach us anything, it is that there is courtroom reality and then there is … reality. What matters is what a skilled attorney can “sell” to a jury of lay people.

Conclusion

Do not think that jumbo awards can only happen to big companies. Do not think that they only happen to trials in Texas. Do not think that it couldn't happen to you. Physicians and hospitals facing professional liability exposures can and should learn from Merck's experience in the first Vioxx trial. They can avoid the risk management and claim headaches that flow from a blockbuster award. Your client's medical practice or institution wants blockbuster medical breakthroughs, happy patients and financial solvency — not blockbuster headlines or jury awards. Read and heed the lessons of Merck's first Vioxx trial and give those clients what they want!

Kevin M. Quinley, a member of this newsletter's Board of Editors, is Senior Vice President of Medmarc Insurance Group, Chantilly, VA. He can be reached at [email protected] or at his Web site, www.kevinquinley.com.