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Merck loses fight to block CEO testimony on Vioxx

LINDA A. JOHNSON

TRENTON, N.J. - Associated Press - Dec. 28, 2004 - Raymond V. Gilmartin, the top executive at troubled pharmaceutical giant Merck & Co., could give testimony as soon as March in some of the dozens of lawsuits filed in New Jersey over Merck's withdrawal of its blockbuster arthritis drug Vioxx.

Ted Mayer, an attorney for Whitehouse Station-based Merck, said Tuesday that scheduling for Gilmartin's pretrial depositions is still being finalized but is expected to be held in March in offices of attorneys on the case. Mayer said his firm, Hughes Hubbard, and a second firm representing Merck, Dechert LLP, had filed a motion to prevent or set constraints on depositions by Gilmartin, Merck's chief executive officer and chairman, and coordinate them with other litigation around the country.

However, state Superior Court Judge Carol E. Higbee in Atlantic County on Dec. 16 issued a verbal order requiring Gilmartin to answer questions from plaintiffs' attorneys about his knowledge of risks associated with Vioxx before Merck voluntarily pulled it from the market worldwide on Sept. 30.

At the time, Merck said it was acting in patients' interests because a new, internal study showed the popular drug for arthritis and acute pain doubled the risk of heart attack and stroke in patients who had used it for 18 months or more. "We believe that when we get a chance to tell our story in court, it'll be clear that Merck did the right thing in terms of its study of the drug and the actions it took," Mayer said. Attorneys for plaintiffs in cases filed in New Jersey did not immediately return telephone messages left Tuesday by The Associated Press.

Consumer activists have argued dangers associated with Vioxx were clear from earlier studies and that company officials downplayed the heart risks. About 2 million people were using Vioxx when it was withdrawn. According to Merck, at least 475 Vioxx personal injury or product liability lawsuits have been filed, including 240 suits in New Jersey.

One suit seeks class-action status on behalf of Vioxx users allegedly injured or killed by the drug; dozens of others seek class-action status for consumers seeking refunds for medication costs, medical monitoring to detect any future harm from use of Vioxx or other remedies. Individual lawsuits allege a range of cardiovascular, gastrointestinal and kidney injuries, Mayer said. The lawsuits filed in New Jersey state courts have been consolidated under Higbee, but none is likely to be the first Vioxx case to come to trial, Mayer said. "We expect we'll probably have a trial in the first half of 2005," he said. "It may be in Texas or Alabama."

Vioxx had been Merck's No. 2 drug, generating about $2.5 billion in annual sales, or 11 percent of company revenues, before Merck withdrew it. The news slashed Merck's market capitalization by $28 billion on Sept. 30.

In trading on the New York Stock Exchange on Tuesday, Merck shares rose 25 cents to $32.20, up from its November low of about $26 but well below its peak earlier this year at nearly $50.

"This is a landmark event for Health Canada," Health Minister Ujjal Dosanjh said.

"It marks the first time in our history that such a forum has been organized specifically to provide an opportunity for members of the public to present their views to one of the department's expert advisory panels."

The drugs, commonly prescribed for arthritis, are sold under the names Celebrex, Mobicox, Bextra and Vioxx.

COX-2 inhibitors were originally promoted as being easier on the stomach than older drugs called standard nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ASA and ibuprofen.

But last year, Merck & Co. withdrew Vioxx from shelves after a study found it significantly increased the risk of heart attack and stroke. Health Canada asked Pfizer Inc. to pull Bextra from the market last month due to concerns it could cause a deadly allergy.

INDEPTH: Details on reports of adverse reactions connected with COX-2 inhibitors

About a dozen independent experts are to hear input from drug companies, researchers and the public in the health ministry's first such public forum on June 9 and 10.

FROM DEC. 23, 2004: FDA recommends restrictions on use of Celebrex, Bextra

A similar forum held earlier this year by the U.S. Food and Drug Administration recommended the drugs remain on the market, but in packages with black box warnings of heart risks. Vioxx could return, it said, but patients would have to sign consent forms.

Several lawsuits have been launched against Health Canada, alleging it failed to act against the drug makers when it was aware of the pills' risks.

FROM NOV. 19, 2004: Study reveals why COX-2 painkillers may cause heart disease

The panel is to be headed by Andreas Laupacis, professor of medicine and health policy management and evaluation at the University of Toronto.

Those who cannot attend the forum but would like to provide input can access the Health Canada COX-2 forum website or call 1-866-558-2946 between 8 a.m. and 2 p.m. EDT weekdays.

Details on reports of adverse reactions connected with COX-2 inhibitors

CBC News Online | December 17, 2004 - Health Canada tracks all reported adverse drug reactions in a database called CADRIS, which stands for the Canadian Adverse Drug Reaction Information System.

The CBC has obtained the database through federal access to information laws. It contains data collected between 1965 and April 30, 2004. (For more on the database, go to Faint Warning, a feature outlining Canada's early warning system for drugs on the market.) cbc.ca/news/adr

CBC News Online ran a series of queries through the database related to COX-2 inhibitors. We were looking for reports of adverse reactions to Celebrex, Vioxx, Bextra and Mobicox. We were looking for:

• All reports of drug reactions where the drug was suspected.
• All reports of serious drug reactions where the drug was suspected.
• The number of deaths associated with the reports of drug reactions where the drug was suspected.
• The number of deaths that involved cardiovascular/cerebrovascular incidents (heart attack/stroke) where the drug was suspected.

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