Merck & Co. proved it could win Vioxx suits Nov. 3 when a jury said the drug was not responsible for the heart attack suffered by Idaho postal-worker Frederick Humeston. More important, the jury decided that Merck gave adequate public warning about the drug’s safety risks.  Experts are split over the reasons for Merck’s victory and its implications for future trials.

    “It was tremendously important for the company to establish the fact that it can win Vioxx cases in front of juries,” said Tom Dewey, partner at Dewey Pegno & Kramarsky LLP.

    Dewey noted that this was an easier case for Merck to win than the first trial, which was decided in Texas this August, because the plaintiff took Vioxx for a shorter period, was still living, and had other heart-related risk factors.

    If Merck had lost this case, “it would have opened practically everyone to litigation,” said John Calfee, resident scholar at the American Enterprise Institute.

    But Evan Schaeffer, a partner at Schaeffer and Lamere PC who is involved in prosecuting Vioxx cases on the Illinois and Missouri border, pointed out that jurors did not decide on the issue of causation.

     “Once they found, as an initial matter, that Merck did nothing wrong, their deliberations stopped,” he said via email. “Although I think Humeston was weaker on causation than Ernst [the Texas trial] there’s no way to know if that fact played a role in the result.”

    Schaeffer said the main difference between the Texas and New Jersey trials was how Merck handled internal documents. 

    “That’s what Merck accomplished in New Jersey,” he said. “Merck’s lawyers were able to put Merck’s internal document in a better light-though a false light, in my opinion.” 

    Merck did a good job of getting jurors to focus on the fact that FDA approved Vioxx and that the company added a warning to the drug’s label at the agency’s request, said Carl Tobias a law professor at the University of Richmond.

    “A lot of it does have to do with the basic core proof of the warnings,” he said. “What Merck did that seemed to work was to stress FDA approval and warnings to emphasize the risk factors that the plaintiff had.”

    The presentation of scientific information was another big difference between the Ernst and Humeston trials, according to Dewey. 

    “Merck did a better job of presenting the science to this jury,” he said. 

    According to published interviews with jury members from the Texas trial, the plaintiff explained the scientific basis of its argument more effectively than Merck. This time around, This time around, Merck selected people who could focus on and ask questions about the scientific issues of the case.

    Another possible factor in Merck’s victory, although no one is sure how much weight it carries, is that the trial took place in the company’s home state. This might cause plaintiffs to place more emphasis on the locations for future trials, according to Calfee.

    “It certainly was not a negative,” Dewey said.

    Going forward, the Humeston result may discourage plaintiffs from filing new suits, Dewey indicated. It will slow down the rate of filing that increased significantly after the Ernst verdict, he predicted.

    Tobias speculated that the gatekeeper role of the judge in the upcoming federal trial could change the way both sides present evidence. Federal judges scrutinize the evidence before it is presented to the jury, he explained. He predicted that this might cause difficulties for the plaintiff.

    But Schaeffer believes that, in spite of this loss, Vioxx plaintiffs have more victories on the way.

    “That’s the nature of the jury system,” he said via email. “Each case is different and it will take quite a few more before anyone can say with certainty how this litigation will end.” 

Articles

Legal experts analyze the differences between the first two Vioxx trials and what allowed Merck to be successful this time around. They also offer insight about what to expect going forward.

Merck Wins Round Two

The Centers for Disease Control’s Advisory Committee for Immunization Practices recommends that all children get vaccinated against Hepatitis A. 

    CDC does not have to follow the advisory committee’s recommendations, but it usually does, said spokesman Curtis Allen. 

    The committee’s recommendation, issued October 17, expands a previous program, launched in 1999, which advised childhood vaccination against the disease in 17 high-risk Western states. That program was highly effective, according to an analysis by CDC scientists published in the July 13, 2005 issue of the Journal of the American Medical Association.

    According to the authors, between 1990 and 1997 the rate of infection in the 17 target states was 4 times higher than in the rest of the country. By 2003 the rate of Hepatitis A infection in these states was in line with the rates in other states, dropping from 21.1 cases per 100,000 in the 1990s to 2.5 cases per 100,000 people-a decline of 86 percent.

    In 1998 nearly 600,000 doses of the vaccine were distributed, the authors found. This climbed to more than 3 million in 2003.

    The results were achieved without the use of strict regulations. Of the 17 states where CDC recommended vaccination for all children, only 6 made vaccination a requirement for enrolling children in school and daycare, according to data updated in August by the Immunization Action Coalition. And of these, two mandated the vaccine only in selected counties.

    This is good news for vaccine advocates. “It’s a lot of work to get a mandate in place,”-because the decision is made by legislators rather than by a medical board- explained Deborah Wexler, director of the Immunization Action Coalition. But in most states, “the disease rates went down a lot without a mandate,” she said.

    The CDC authors credited some of this decrease to the “herd effect,” in which overall infection rates decrease as a result of lower person-to-person transmission through “modest levels of vaccination coverage.” The herd effect is also credited with reducing adult infections.

    The only potential issue is securing funding to protect children whose insurance plans will not cover the vaccine, Wexler said.

    “It’s going to take a while to put things in place so that the funds are secured,” said David Neumann, executive director of the National Partnership for Immunization.

    He also predicted resistance from some parents, because there are already so many recommended or required childhood vaccines.

    “This is not a vaccine that is going to be a problem for parents to accept,” she asserted.  Even if they have to pay for it out-of-pocket, she said.

Doctors are likely to include give the vaccine as a matter of routine in private practices, Allen said, because it is also recommended the American Academy of Family Physicians and the American Academy of Pediatrics. 

    Allen said CDC would formally publish its recommendation in the Morbidity and Mortality Weekly Report within the next two months.

The success of a 1999 program to vaccinate children in high-risk areas against Hepatitis A prompted the Advisory Committee on Immunization Practices to recommend universal use. But the vaccine may face minor hurdles from insurance companies and states.

Pharmaceutical Executive-11-08-2005

Merck Wins Round Two

Advisory Committee Recommends Hepatitis A Vaccine for All Children