Merck and the Vioxx Defense

Chase Adams & Laura Ringling

This paper discusses the Vioxx litigation, examining and analyzing the verdicts from each lawsuit to date. Further, it sets out arguments favoring and disfavoring Merck’s actions. Did Merck act unethically in its marketing and research of the popular painkiller, or is the company simply the victim of overzealous attorneys and runaway juries?

I.               INTRODUCTION

In September of 2004, Merck withdrew one of the company’s most popular pain-relievers from the market, after a clinical trial showed that long-term use of the drug Vioxx significantly increased the risk of heart attacks.[1]  At the time of the withdrawal, Vioxx was used by over 20 million people in the United States, and it was estimated that as many as 100,000 individuals might have suffered heart attacks as a result of their usage; over 80 million people worldwide prescribed to the pain reliever.[2]  Merck claims to have adequately warned the public about the risks associated with Vioxx.[3]  However, media reports indicate that Merck knew of the dangers associated with Vioxx long before its removal from the market, yet the company still aggressively marketed the drug to patients and doctors.[4] 

Traditionally, Merck is a company known for its ethical practices and social conscience.  In fact, Merck’s mission statement maintains that “[t]he mission of Merck is to provide society with superior products and services by developing innovations and solutions that improve the quality of life and satisfy customer needs . . . .”[5]  In recent years, Merck has gained recognition for its development, production, and distribution without charge of Mectizan, a drug which prevents river blindness.[6]  Merck has dispensed more than 250 million doses since 1987, and 40 million patients a year benefit from its programs.[7]  And in 2005, Merck launched the Merck Prescription Discount Program, which offered many of its medications to uninsured Americans at a discount of 15% to 40%.[8]

Today, however, Merck is battling a much different corporate image.  Merck currently faces over 27,000 lawsuits by individuals who have taken Vioxx and subsequently suffered heart attacks or stokes.[9]  Merck maintains that the company has behaved responsibly, claiming that the drug was pulled from the market as soon as researchers expressed concern about its potential risks.[10]  According to Kent Jarrell, a spokesman for Merck’s legal defense team, “[w]e believe that as a company, we have acted responsibly, from researching the drug prior to approval, to monitoring the drug while it was on the market and to voluntarily withdrawing the drug when we did.”[11] 

II.             THE LITIGATION

Merck is faced with over 27,000 lawsuits over Vioxx. [12] Of the cases that have reached verdicts, Merck has been successful in nine of these cases, while the plaintiffs have received verdicts in five.[13]  Merck has vowed to contest every case regarding Vioxx and has spent more than $1 billion in legal fees.[14]  And their strategy is working.[15]  While estimates of Merck’s ultimate liability were once as high as $25 billion, that number has now dropped closer to $5 billion.[16]

In August 2005, a jury in Arlington, Texas awarded the family of Robert Ernst $253.4 million.[17]  Jurors stated that the “$229 million in punitive damages stemmed from Merck's delay in adding a warning label so the company could avoid losing market share.”[18]  Ernst, a 59-year-old triathlete, died in his sleep after taking Vioxx for approximately eight months.[19]  Pursuant to Texas state law, however, the trial judge lowered the damages to $26.1 million.[20]  Counsel for Merck stated that “the verdict was not supported by proper evidence and that they expect to overturn it on appeal.”[21]  Attorney Ted Mayer believes that Merck acted responsibly.[22]  According to Mayer, “[t]his case isn’t over yet.”[23]

            On November 3, 2005, an Atlantic City, New Jersey, jury gave Merck its first verdict.[24]  The jury determined that Vioxx did not cause Frederick Mike Humeston’s heart attack.[25]  Humeston, a 60-year-old Idaho postal worker, claimed Vioxx caused his heart attack in 2001 after less than two months of intermittent use.[26]  In an eight to one vote, jurors sided with Merck.[27]  The jurors found that Merck scientists did not know of any increased risks of heart attack or stroke associated with Vioxx in 2001 and therefore did not have an obligation to warn physicians.[28]  However, this victory for Merck was brief.  Judge Carol Higbee ruled in August 2006 that “evidence uncovered since the verdict warranted a new trial.”[29]  Humeston won a $47.5 million award during his second trial against Merck in March 2006.[30] 

            After a mistrial was declared in December 2005, a federal jury in New Orleans determined in February 2006 that Vioxx did not cause the heart attack of Richard Irvin, a 53-year-old Florida man who had taken the drug for less than one month.[31]  The first trial was held in Houston, and ended with the jury deadlocked in an eight to one vote in favor of Merck.[32]  The second jury reached a verdict in favor of Merck, but this victory was also short-lived.[33]  According to Judge Eldon E. Fallon, one of the experts who testified for Merck misrepresented his qualifications at trial.[34]  To date, this case has not yet reached a verdict.

            On April 5, 2006, jurors in Atlantic City, New Jersey, found for plaintiff John McDarby, ordering Merck to pay $13.5 million to the 77-year-old man.[35]  McDarby suffered a heart attack in 2004 after taking Vioxx for four years.[36]  Jurors believed that McDarby was a victim of consumer fraud, concluding that Merck concealed the dangers of Vioxx.[37]  The McDarby case was also tried with Thomas Cona’s case.[38]  However, the same jury that rendered a verdict against Merck in the McDarby case did not agree that Vioxx caused Cona’s heart attack.[39]

            Merck lost another case in April 2006 when a state jury in Rio Grande City, Texas, awarded $32 million to the widow of Leonel Garza.[40]  Garza, a 71-year-old man with a 20-year history of heart disease, suffered a heart attack after taking Vioxx for less than one month.[41]  This was the first case in the country where a jury found that short-term usage of Vioxx was linked to heart attacks.[42] 

            On July 13, 2006, an Atlantic City, New Jersey, jury concluded that Vioxx was not responsible for 68-year-old Elaine Doherty’s 2004 heart attack.[43]  “The case was the first in which jurors considered whether Merck failed to warn patients about the drug’s cardiac risks, rather than just doctors as in prior trials.”[44]  The jury found that while Merck had warned physicians about Vioxx’s cardiac risks, it failed to properly warn Doherty.[45]  Nevertheless, the jury concluded that the drug was not a major factor in the woman’s heart attack.[46]  Merck contended that although Doherty had taken Vioxx for two years, cardiac risk factors such as obesity, diabetes, high blood pressure, and high cholesterol were responsible for her heart attack.[47] 

            From August 2006 to January 2007, Merck was successful in defending five of six cases brought before the courts.  Merck’s fist success during this period came on August 2, 2006, when state jurors in Los Angeles, California, determined that Vioxx was not responsible for the heart attack suffered by 71-year-old Stewart Grossberg.[48]  Jurors concluded that “there was no scientific evidence linking Grossberg's intermittent use of the drug with increased risk of heart disease.”[49]  However, later this same month, a federal jury in New Orleans returned a verdict in the amount of $51 million in favor of Gerald Barnett.[50]  Barnett, a 62-year-old retired FBI agent, suffered a heart attack after taking Vioxx for approximately two years.[51] 

            Beginning in September 2006, Merck won four consecutive jury verdicts.  On September 26, 2006, a New Orleans federal jury concluded that 57-year-old Robert Gary Smith’s heart attack was not caused by his five-month use of Vioxx.[52]  And on November 16, 2006, a federal New Orleans jury found in favor of Merck, rejecting Ron Mason’s claim that his heart attack at age 61 was caused by taking Vioxx.[53]  Mason was seeking $690,000 in lost wages, medical expenses and non-economic damages for his 2003 heart attack.[54]  Again on December 13, 2006, another New Orleans federal jury exonerated Merck for the heart attack of Anthony Dedrick, 51, who claimed his heart attack was caused by taking Vioxx for six months.[55]  Only two days later, Merck won again.[56]  After 11½ hours of deliberation, an Alabama federal jury rejected Gary Albright’s claim that Vioxx caused his heart attack in 2001.[57]  Albright sought to convince jurors that Merck suppressed information regarding the drugs risk to certain patients.[58]  “Jurors told lawyers after the verdict that Albright’s progressive health problems were a factor in their verdict.  They said they were impressed with Merck scientists and physicians who testified during the trial, and the defense’s focus on the scientific aspects of the case. . . .”[59]

            Merck claimed victory again on March 27, 2007 when a jury in Madison County, Illinois rejected Frank Schwaller’s claim that Vioxx caused the death of his wife in 2003. [60]  Merck’s lead defense attorney, Dan Ball, was pleased with the jury’s verdict, stating:

The evidence showed that Merck acted responsibly and that Vioxx was not the cause of Mrs. Schwaller's sudden cardiac death . . . [u]nfortunately, Mrs. Schwaller had multiple risk factors for sudden cardiac death including a family history of heart disease, as well as diabetes, high blood pressure and morbid obesity. The combination of these risk factors put her at increased risk for sudden cardiac death, having nothing to do with Vioxx.[61]

With thousands of cases pending, no clear pattern has developed regarding the Vioxx litigation.  However, Merck’s defense strategy is clear.  The company is defending every case at all costs.  None of these plaintiffs have been perfect.  In fact, most were at risk for cardiovascular disease without the increased threat presented by Vioxx, and Merck is relying heavily on this factor to persuade juries that even absent the use of Vioxx, these plaintiffs would have nevertheless suffered a heart attack or stroke.[62]  Some juries have agreed with Merck, while others have not.  No clear pattern is perceptible.  However, subtle trends do exist.  

Merck’s victories have come in cases where the plaintiff’s use of Vioxx was intermittent, untimely, and short-term.[63]  According to plaintiff lawyer Mark Lanier, “[e]very plaintiff who has lost has not been able to prove that the client was on Vioxx at the time of the heart attack.”[64]  Juries have tended to be more sympathetic where the plaintiff has established long-term Vioxx usage continuing until the time of the heart attack.[65]

III.            THE KNOWLEDGE

A. Merck’s Defense

            Merck has continued to defend the Vioxx cases on two grounds.  First, Merck contends that the company acted responsibly when it voluntary withdrew Vioxx from the market in 2004.[66]  Therefore, Merck believes it adequately warned consumers of the heart risks associated with Vioxx and never knowingly endangered patients.[67]  Second, Merck argues that no plaintiff has ever met his or her burden of proof that Vioxx was the cause of a heart attack.[68] 

            While press coverage has suggested that Merck deliberately concealed evidence regarding the risks of Vioxx, the company strongly denies this allegation.[69]  Merck argues that no reliable scientific evidence indicating that Vioxx increased cardiovascular risk existed prior to September 2004.[70] 

The news of Vioxx’s dangers came five years after Merck put the drug on the market.[71]  Vioxx had become one of the world's most aggressively marketed drugs.[72]  It was advertised in magazines and in television commercials, with celebrity endorsements from former athletes Dorothy Hamill and Bruce Jenner.[73]  After a clinical study in late September of 2004 revealed that Vioxx usage doubled the risk of heart attack and stroke, Merck immediately contacted the Food and Drug Administration (FDA).[74]  In a meeting with the agency on September 28, 2004, the company informed the FDA that it would voluntarily withdraw Vioxx from the market.[75]  Two days later Merck officials publicly announced the worldwide withdrawal of Vioxx.[76]

            Merck maintains that it has continuously acted responsibly.  However, data from a company study shows that researchers had been warning about Vioxx’s potential cardiovascular risks since 2000, and Merck never reported this information to the FDA.[77]  The company claims that this data was not definitive.[78] 

Merck's vice president for global regulatory development, Dennis Erb, said the company's actions were timely and appropriate, citing Merck’s June 2000 submission of the results of a study known as VIGOR.[79]  VIGOR results indicated a four-time increase in the risk of serious cardiovascular events as compared to Naproxin.[80]  “We believe Merck acted appropriately and responsibly to extensively study Vioxx after it was approved for marketing to gain more clinical information about the medicine,” he said.[81]  Erb further explains that the company promptly disclosed the results of these studies to the FDA, the scientific community, and the media.[82]  Merck did not, however, directly contact the physicians prescribing Vioxx.[83]

B. Merck’s Opposition

            The controversy surrounding Vioxx has existed since the drug was introduced by Merck in 1999.[84]  In fact, internal Merck documents indicated that company executives and scientists were concerned about Vioxx as early as 1997.[85]  However, plans to conduct a study of the heart risks associated with the drug were rejected at this time.[86] 

According to an internal memorandum from November 1996, Merck was facing a marketing dilemma regarding Vioxx.[87]  Studies on Vioxx became available in 1998 and 1999 indicating that the drug did not alleviate pain any better than traditional pain-relievers such as aspirin or ibuprofen.[88]  This was problematic because the cost of Vioxx was close to $3 per pill; in contrast, traditional over-the-counter pain relievers cost only pennies per dose.[89]  In order to market the drug successfully, executives considered conducting a study to prove that Vioxx was gentler on the stomach than these traditional pain-relievers.[90]  The problem with this type of study was that patients using Vioxx could not concurrently take aspirin, which reduces the risk of heart attacks.[91]  Merck officials recognized that there was “a substantial chance that significantly high rates” of cardiovascular problems would occur if patients could not take both Vioxx and aspirin.[92]  These were clinical test results that Merck was not interested in producing.[93]

            Although the cardiovascular risks associated with Vioxx seemed obvious, Merck did not conduct any clinical trials solely dedicated to determining these risks.[94]  Instead, the company conducted trials aimed at highlighting the potential benefits of Vioxx.[95] 

However, it is unclear whether Merck is solely at fault for the lack of information surrounding the potential cardiac risks associated with Vioxx.[96]  Questions remain about how the FDA could have allowed the drug to be sold for so long with so much evidence mounted against it.[97]  “Even before Vioxx’s approval, an F.D.A. drug reviewer had written that Vioxx could conceivably hurt the heart.  Studies of the drug at that point, however, showed nothing more than a suggestion of a risk.”[98]  At this point, the FDA did not conduct any further investigation.  After the results of Merck’s VIGOR study were released, the FDA finally took action, and hired an independent cardiologist to analyze the studies and summoned a panel of experts to “discuss the data publicly.”[99]  In February 2001, the panel met, and several members expressed concern over Vioxx’s cardiovascular risks.[100]  However, no one suggested that the drug be withdrawn from the market.[101]  The FDA did suggest that Merck conduct a study designed solely to analyze the heart risks associated with the drug.[102]  However, after extensive discussions the FDA sided with Merck officials, concluding that such a study would be difficult to conduct and could be potentially unethical.[103]  Although the FDA did not require Merck to conduct an additional study, the agency did require that a label cautioning that patients with a history of cardiovascular problems use the drug with care.[104] 

While many warning signs and data existed regarding the cardiovascular risks associated with Vioxx, Merck continued to aggressively market the drug to doctors and patients.[105]  Internal documents indicate that Merck sales personnel took extensive measures to deflect doctor’s questions about the safety of Vioxx.[106]  The company’s sales representatives were also advised to avoid discussion regarding studies that linked Vioxx with cardiovascular risk.[107]  The one thing doctors needed to know most about Vioxx was its risks to patients.  Merck seemed to respond to these inquiries with “disinformation and censorship.”[108] 

In addition to Merck’s aggressive and misleading marketing strategies, the company has also been blamed for harassing critics of Vioxx.^[109]  “Two leading scientists said . . . that they were pressured to back off criticism of the painkiller Vioxx after warning that it might cause heart attacks and strokes in some patients.”^[110]  However, Merck may not be the only one guilty of silencing critics. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, stated that he was pressured to keep quiet when he questioned the safety of Vioxx with other FDA officials.^[111]  Graham accused Merck of designing some of its studies of the drug to exclude patients with heart problems who likely would run a higher risk of developing cardiovascular problems while taking Vioxx.

Additionally, a professor at Stanford University’s medical school, Gurkirpal Singh, stated that his superiors were contacted by the senior executive of Merck, who suggested that Singh would encounter problems with his career if he continued to raise concerns about the company’s drug.[112]  Singh contends Merck knew questions about Vioxx’s safety existed even before it was introduced into the market; he also claims that Merck designed studies to emphasize the benefits of Vioxx while minimizing the cardiovascular risks.^[113]  Despite these accusations, Merck continued to defend the safety of their product.^[114]

C. Merck’s Escalating Legal Battle

            The thousands of civil lawsuits regarding Vioxx may only be the beginning of a vigorous uphill legal battle for Merck.  In addition to the extensive civil litigation, the United States Department of Justice has subpoenaed the company as part of a criminal investigation into Merck's handling of Vioxx.[115]  The Justice Department has requested information from Merck regarding the company's research, marketing and selling activities for Vioxx as part of a federal healthcare investigation under criminal statutes.[116]  “The focus of the investigation could be centered on whether or not Merck misled regulators or even caused federal health programs to pay for Vioxx when its use was unwarranted.”[117] 

Merck has also announced that the U.S. Securities and Exchange Commission has commenced an informal inquiry investigating whether Merck properly informed investors about the results of clinical trials and other probing research that exposed the drug's risks.[118]

IV. CONCLUSION

It is clear that profits Merck generated from Vioxx may be effectively wiped out by the pending litigation.  While many have questioned whether these lawsuits are warranted or whether they are the result of overzealous attorneys and greedy clients, it seems to be quite obvious that the litigation is well-founded.  Evidence exists to indicate that Merck knew of the cardiovascular risks associated with Vioxx years before the drug was pulled from the market.  However, the company continued to aggressively market Vioxx even in the face of this overwhelming data.  Thus far, Merck’s zealous defense strategy has been successful; juries have been predominantly siding with Merck.  However, as more and more information is revealed regarding Merck’s hidden research and shady marketing tactics, it becomes more likely that juries will begin punishing the company. One thing remains clear:  Courthouses around the country will remain clogged with Vioxx cases for years to come.