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Merck Defends Vioxx Strategy, Releases Arcoxia Data


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-08-30-2006
Volume 0
Issue 0

Company faces two Vioxx setbacks in court as it prepares to reveal safety data on its cox-2 successor.

Merck has vowed to stay the course on its legal strategy as it continues to face setbacks in court over cases involving Vioxx (rofecoxib).

The company is defending its game plan as it releases the first set of safety data for its next generation painkiller Arcoxia (etoricoxib).

A federal jury in New Orleans earlier this month found that Vioxx had caused a heart attack in a 58 year-old South Carolina man. Then, in a separate New Jersey case, a judge set aside a previous Merck victory after reading an "expression of concern" in The New England Journal of Medicine (NEJM).

The cases were Barnett v. Merck and Humeston v. Merck, respectively.

"We remain confident in the strength of our defense, and we remain committed to the fight and to the strategy of defending these cases on an individual basis," said Ted Meyer, an attorney at Hughes Hubbard & Reed and a member of Merck's litigation team.

"We are going to have losses along the way," added Phil Beck, one of Merck's lead litigators and founder of firm Barlit, Beck, Herman, Palenchar & Scott. "We recognize that that's part of the vagaries of the legal system and the company is committed to going forward and defending each case on the merits as it comes."

Members of Merck's legal team addressed analysts and the media on a conference call. They reiterated that they expect to wage a long legal battle, and explained the necessity behind it.

"Our message is resonating with juries in a lot of places and in a lot of situations," Meyer said. "You're going to have different results depending on your jury, depending on the facts of your individual case, and so on. And that's why we have to continue to look of these cases individually."

James Etscorn, a partner at Baker Hostetler who is not working with Merck's legal team, noted that Merck is taking a "somewhat unforeseen strategy."

Most companies that faced a recall in the past have opted to settle cases, rather than fight them individually. But he noted that the nuances in the published data--as well as the larger question of whether Merck adequately warned the medical community of heart risks--separates the Vioxx cases from others.

"People want to second-guess Merck's legal strategy, but it's too early to tell how this will play out," Etscorn said, adding that the appeals courts will have the final word on these cases. "I think their strategy has seen some success. These are not the type of cases that can be decided through class action status."

Merck has now litigated nine cases, lost four, and had one victory set aside.

Separately, Merck has released preliminary Arcoxia data suggesting that the drug's cardiovascular risk profile is similar to the non-steroidal anti-inflammatory drug diclofenac.

The company was guarded about the details of the data, saying that the full results of the MEDAL trial would be released in a peer-reviewed paper and at medical meetings.

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