Case Facts

THE OTHER SIDE OF THE STORY
THE VIOXX DRUG CASE

The verdict in the Vioxx case is a clear example of how our civil justice system works to protect our rights as American citizens, allowing ordinary Americans to hold even the largest and wealthiest corporations accountable when they put their bottom line before the health and safety of the public.

The facts presented during the Vioxx trial showed that Merck distributed and promoted Vioxx without properly disclosing the dangers of the drug. The following summarizes some of the key facts of the case and what several jurors had to say about the case, which were highlighted by the media during the course of the trial.

Early scientific studies indicated that Vioxx increased heart risks

Internal Merck documents indicated that the company was aware of the problems with Vioxx as early as 1997. In fact, the company's top scientist stated in March of 2000 that a clinical trial of Vioxx confirmed that the drug had heart risks. Despite their knowledge of these problems, Merck aggressively marketed the drug.

• "Mr. Lanier [the plaintiffs attorney] offered jurors a trove of company documents and e-mail messages that revealed how Merck researched Vioxx's heart risks and presented what it knew to doctors and consumers. The documents showed that scientists at Merck were worried about Vioxx's potential cardiovascular risks as early as 1997, two years before Merck began selling the drug. 'The possibility of increased C.V. events is of great concern,' Dr. Alise Reicin, a Merck scientist, wrote in a 1997 e-mail message; 'C.V. events' is scientific shorthand for cardiovascular problems like strokes or heart attacks. 'I just can't wait to be the one to present those results to senior management,' Dr. Reicin's message continued. The documents also revealed that Dr. Edward M. Scolnick, who at the time was Merck's top scientist, said in March 2000 that the largest clinical trial ever conducted of Vioxx confirmed that Vioxx had heart risks, as he had feared." [The New York Times, 8/21/05]
  
• "Dr. Jerry Avorn, a professor at Harvard Medical School and frequent critic of the drug industry, said he was not surprised that the jury responded as vehemently as it did. 'Even as a seasoned observer of drug company affairs, I have been surprised at the way Merck handled the emerging evidence about cardiac risk with this drug,' Dr. Avorn said. 'There was an element of the Watergate tapes that I was reminded of: many people had been critical of Nixon for a long time, but even Nixon's critics did not expect to find the documentation of their worst fears made so clearly evident.'" [The New York Times, 8/21/05]
  
• "With the help of Dr. David Egilman, another of his expert witnesses, Mr. Lanier also clarified the chronology of Merck's evolving knowledge of Vioxx and its risks. By presenting company documents and e-mail messages among top Merck scientists, Mr. Lanier has shown that Merck was concerned about Vioxx's possible heart risks even before a 2000 clinical trial -- called Vigor -- showed Vioxx caused five times as many heart attacks as naproxen, an older painkiller." [The New York Times, 8/6/05]

Despite problems, Merck appeared to have rushed approval for Vioxx

Even though Merck was aware of the problems with Vioxx, the company tried to rush federal approval of the drug. Documents presented during the trial seem to indicate that the company was more concerned about competition from rival drug makers than they were with health and safety of consumers.

• "On Friday, for example, Mr. Lanier staged a withering examination of Dr. Alan S. Nies, a retired Merck scientist who led the Vioxx development program in the 1990's. The lawyer presented documents that appeared to show that Merck tried to rush federal approval for Vioxx because it feared that Celebrex, a competing drug by Pfizer, would get approval first." [The New York Times, 8/6/05]
  
• "Before Lanier began drilling Nies, he told Merck lawyer Joseph Piorkowski that there was no race to get Vioxx on the market before Celebrex. Nies, who retired from Merck in 2002 three years after Vioxx went on the market, also told Piorkowski it was 'absolutely false' that Merck minimized safety to rush Vioxx to consumers. However, Nies' 1996 plan identified the Celebrex market goal of late 1998 and set the same goal for Vioxx. The document also noted an 'accelerated and compressed' drug development strategy, or beginning some studies before others were finished. 'That's called efficiency,' Nies said. 'It's called recklessness,' Lanier countered. 'It's not reckless,' Nies said." [Associated Press, 8/5/05]

Merck's aggressive marketing practices were highly misleading

In a misleading 2001 letter to doctors, the company clearly understated the risks that patents would be exposed to by using Vioxx. Merck even produced a game called "dodgeball" to teach pharmaceutical representatives how to avoid answering tough questions about their new blockbuster drug.

• "In a 2001 letter to doctors, Merck seriously understated the heart risks faced by patients taking its painkiller Vioxx, according to evidence presented Tuesday in the first Vioxx lawsuit to reach trial. In the letter, Merck reported that patients taking Vioxx in the largest clinical trial of the drug ever, only 0.5 percent had incurred 'cardiovascular events,' or heart and circulation problems. That would mean only about 20 patients among the more than 4,000 who took Vioxx during the study. But in fact, 14.6 percent of the Vioxx patients -- or 590 people -- had cardiovascular troubles while taking the drug, according to Merck's own report on the study to federal regulators. And 2.5 percent, or 101 people, had serious problems, like heart attacks. Merck sent the letter to thousands of doctors, including in April 2001 to Dr. Brent Wallace, who had prescribed Vioxx to Robert Ernst. Mr. Ernst, who was 59, died suddenly in May 2001 after taking Vioxx for eight months, and his family is suing Merck, claiming the drug caused his death. . The gap between Merck's internal analysis of the study and its letter to physicians may undercut a crucial aspect of the company's defense: that Merck fully disclosed Vioxx's potential heart risks to doctors and patients during the five years the drug was on the market." [The New York Times, 7/20/05]
  
• "Mr. Lanier also introduced a marketing videotape that showed Merck sales representatives being trained to view doctors' concerns about Vioxx's heart risks as 'obstacles' to be avoided or dismissed. Another marketing document taught representatives to play 'Dodgeball' when doctors voiced concerns." [The New York Times, 8/21/05]
  
• "Merck told its sales representatives that its painkiller Vioxx did not increase the risk of heart attacks, according to a Merck training video played on Wednesday for jurors in the first Vioxx lawsuit to reach trial. The video, which had never before been publicly shown, also depicts actors playing Merck representatives avoiding a question about Vioxx's potential to increase blood pressure -- a documented side effect. While the training tape was never shown to doctors or consumers, its existence may further undercut Merck's claim that the company properly disclosed Vioxx's risks during the five years the drug was on the market. In the video, an actress playing 'an obstacle' to Vioxx sales says, 'I'm afraid Vioxx causes M.I.'s' -- a reference to myocardial infarctions, or heart attacks. In response, an actress playing a Merck sales representative says, 'That's not true.' . Merck made the videotape in 2000, as it struggled to increase Vioxx sales despite concerns by doctors and independent scientists that the drug might damage the heart." [The New York Times, 7/21/05]

Merck worked to discredit those doctors not prescribing Vioxx

Doctors who weren't fooled by Merck's deceptive marketing of Vioxx were targeted by the company. Merck worked to discredit these doctors and even threatened Stanford University scientists who questioned the drug.

• "He [Mr. Lanier] also questioned internal Merck documents that said the Vioxx sales staff was to 'neutralize' or 'discredit' doctors who refused to back prescribing Vioxx." [The Houston Chronicle, 7/20/05]
  
• "Houston litigator Mark Lanier questioned Nancy Santanello, head of Merck's epidemiology department, about an internal list of 36 doctors identified as 'physicians to neutralize' in an e-mail circulated two months after the popular painkiller went on the market in 1999. 'Attached is the complete list of 36 physicians to neutralize with background information and recommended tactics. You will notice that some have already been 'neutralized,'' the e-mail said. It also said a previous e-mail had a subset of the 36 physicians 'we would like to get involved in Merck clinical research' and that the e-mail's recipient should 'be aware of our most challenging (and also most vocal) national and regional physicians.' Santanello said the term 'neutralize' was a marketing strategy to educate doctors about Vioxx." [Associated Press, 7/19/05]
  
• "Lanier also showed a January 2001 letter from Stanford Medical School professor Dr. James Fries to former Merck CEO Ray Gilmartin complaining that Merck researcher Louis Sherwood had called him to try to get him to make another professor stop saying negative things about Vioxx in lectures. Sherwood warned that if the professor didn't stop bashing Vioxx, he would 'flame out' and 'there would be consequences for myself and Stanford,' Fries wrote." [The Houston Chronicle, 7/19/05]
  
• "Lanier also presented documents showing that Vioxx sales staff members at one time earned a $2,000 bonus if one of the doctors they called on prescribed Vioxx more than 55 percent of the time and another $2,000 if that rate exceeded 61 percent." [The Houston Chronicle, 7/20/05]

In Their Own Words
Members of the jury discuss their decision to hold Merck accountable

On sending a message to Merck and the drug industry:

• "'We expect accountability, we expect them to be open with us, we expect them to be honest with us.' Marsha Robbins, the forewoman, "after a jury found the maker of Vioxx had acted recklessly in selling it despite knowledge of its risks."" [The New York Times, 8/20/05]
  
• "'Stop doing the minimum to put a drug on the market,'" juror Derrick Chizer said. 'Go out there and do your very best. ... Merck makes a lot of medicines. They're staking our lives. Be responsible.'" [The Dallas Morning News, 8/20/05]
  
• "Juror Derrick Chizer, who voted for Ernst, said the majority of jurors believed a heart attack triggered the Texas man's fatal arrhythmia, or irregular heartbeat. 'It could have been prevented,' he said. 'That is the message (to pharmaceutical companies). Respect us.'" [The Associated Press, 8/20/05]
  
• "[Juror Derrick] Chizer said the message jurors wanted to send to Merck was for the company to take their responsibility seriously. 'Every life counts to us. They should be responsible. If they care, then show it,' said Chizer, 43, of Pearland, who works for the Social Security Administration." [The Houston Chronicle, 8/20/05]
  
• "Juror Lorraine Blas: "We wanted to make a statement. We wanted to let all the companies know that they can't do this. It's not right. You can't hide information. You have to give all the information." [The Early Show, CBS News Transcripts, 8/20/05]
  
• "'They needed to be held accountable for putting a drug out there that shouldn't be out there,' said Stacy Smith, a 21-year-old child care provider who stood with the majority in the 10-2 vote in favor of the man's widow, Carol Ernst. 'I want them to listen,' said Marsha Robbins, a 53-year-old homemaker who was the presiding juror and the oldest of the panel. . David Webb, a 20-year-old electrician and one of the two youngest jurors on the panel, said he went into deliberations supporting Ernst, 'but I wanted to give the defendants a chance. We just really didn't find anything that helped them.'" [Associated Press, 8/19/05]
  

On Merck's decision to market Vioxx despite knowing the problems with the drug:

• "One of the jurors, 21-year-old Stacy Smith, said she was shocked at evidence that showed the company knew the dangers of Vioxx long before it withdrew the drug. 'They knew, and they still put it out anyway,' she said." [Sunday Express (U.K.), 8/21/05]
  
• "Several jurors said that company documents showed Merck seemed to care more about profits from the drug than the public's welfare. Stacy Smith, 21, said she was swayed by documents written by Merck executives. 'They knew,' she said, 'and they still put [Vioxx] out.' . Juror Lorraine Blas, 41, said she reviewed several documents in the jury room and found a particularly damaging Merck e-mail on cardiovascular events and testing dating back years. 'I felt Merck knew something was going on as early as 1997,' she said. Juror Derrick Chizer, a Social Security service representative, said he was irritated that Merck failed to send any executives who were responsible for bringing Vioxx to market to the trial. 'Not one bigwig from Merck came down. Not one of them took the time,' Chizer said. 'One death in my life would make a difference. Why wouldn't it make a difference to them?'" [Los Angeles Times, 8/20/05]
  
• "Juror Lorraine Blas: "The evidence there - after reviewing all the evidence in the jury room, I decided from looking at the paperwork they knew the problems this medication was causing and they hid it from us. Rather than telling us the good and the bad, they only told us the good." [The Early Show, CBS News Transcripts, 8/20/05]
  
• "Merck did not let us know the full problems of the drug,' juror Rhonda Wade said. 'I was shocked.'" [The Dallas Morning News, 8/20/05]
  
• "This case certainly opened my eyes,' said juror Rhonda Wade, a 41-year-old mother of four from nearby Clute, Texas. 'They ignored an FDA warning letter about their marketing and they didn't give [regulators] all of the information.' 'I will probably never take another pill without totally investigating it, questioning my doctor and pharmacists and reading all the information I can,' Wade said." [Chicago Tribune, 8/20/05]
  
• "Juror Stacy Smith: "The issue, to me, was, did Merck know before they put the drug on the market, and when they did, why didn't they do something about it immediately?" [World News Tonight, ABC News Transcripts, 8/19/05]
  
• "Look at the evidence,'' said Marsha Robbins, the forewoman, when asked whether the award was excessive. 'They knew they had a problem,'' she said of Merck, the maker of Vioxx. . One factor that swayed the jury, Ms. Blas said, was another look at Merck's labeling of Vioxx, even after the company began warning doctors that the drug could be linked to 'cardiovascular events' like heart attacks and strokes. 'In the first label, it didn't jump out at you that C.V. events were happening,' Ms. Blas said, referring to a cardio vascular event. 'You had to dig three levels to see it.'" [The New York Times, 8/20/05]
  

On how the jury determined the punitive award amount:

• "Juror Rhonda Wade: "Our award was based on the fact that once they figured out they had no choice to make the [warning] label change, they chose to stall it in order to make as much as $229 million. And we don't want them to stall. We want them to tell us the truth, and be responsible. . Looking through their evidence, and time after time, you could see where they knew about the CV [cardiovascular] events and how important it was and they didn't do anything about it. That's what made up my mind." [Newsnight with Aaron Brown, CNN, 8/19/05]
  
• "Lisa Stark, ABC News Reporter (Voice Over): "The case against Merck relied heavily on internal company documents including ones that seemed to show Merck knew about possible heart risks, even before Vioxx went on the market. Jurors were also told Merck delayed strengthening Vioxx's warning label. And that's how they decided on the amount of punitive damages." Juror David Webb: "$229 million was the amount of money that Merck would gain if they put off changing the label." [Good Morning America, ABC News Transcripts, 8/20/05]
  
• "Carol Ernst was awarded $ 253.45 million Friday, including $ 229 million in punitive damages. 'That was a number they kept saying over and over,' juror Stacy Smith, a 21-year-old college student, said. 'It was in our mind. When you're sitting there for five weeks and that number kept being repeated, the number stuck in our mind.'" [Houston Chronicle, 8/20/05]
  
• "Because of caps under state law, Hardin will have to reduce the amount of the punitive damages to $ 1.65 million, making the total $ 26.1 million. Juror Rhonda Wade, 41, of Clute, said those on the seven-man, five-woman jury were not aware of a cap on punitive damages. 'We assumed that no matter what the number, it would be cut back,' she said. 'We wanted to get the message across.'" [The Houston Chronicle, 8/20/05]
  
• "In interviews after the decision, jurors said they had made the large punitive award to send a message that drug makers must disclose the risks of their medicines. 'Respect us, that's the message,' said Derrick Chizer, a juror. 'Respect us.'" [The New York Times, 8/20/05]
  
• "When you write that figure ($ 229 million), it means Merck is going to have to get responsible,' said Rhonda Wade, 41, of Clute. 'It's not the money,' added Marsha Robbins, 53, of Freeport, who served as the presiding juror. 'It's accountability.'" [The Houston Chronicle, 8/20/05]
  

Tort Reform Beneficiaries & Accountability

According to filings with the Securities and Exchange Commission, Merck's after tax net profit for the year ended December 2004, was $5.813 Billion. Their after tax net profit margin was 25.3%, which is larger than that of Bristol Myers Sqibb, Eli Lilly & Co, Pfizer and any other competitor.

The original $229 Million punitive damage award is only 4% of Merck's net after tax profit for last year. That sum would hardly make a "blimp" on Merck's radar screen.

The reduced punitive damage award of $1.65 million, which was mandated by so called Tort Reform legislation (Texas Civil Practice & Remedies Code § 41.008), is less than 1% of Merck's net after tax profits for last year. That sum is no more significant than what Merck already expects to lose due to round off errors.

In the last five years, Merck has spent $30.39 Million (almost 18.5 times the reduce punitive damage award), to lobby the U.S. Congress for passage of so called Tort Reform legislation which would protect pharmaceutical companies. It that legislation had been law, today, Merck would have been virtually off the hook. In fact, this case would probably have not been brought, let alone go to trial at all.

David Graham, a scientist at the Food and Drug Administration, in testimony before the U.S. Congress, said that Vioxx contributed to the death of as many as 55,000 people in the United States.

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