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Thursday, September 8, 2005

Vioxx trials to pain industry

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As attorneys prepare for the start of the second Vioxx trial Monday in Atlantic City, N.J., both sides say the outcome from the first trial signals vast changes ahead for the drug industry.

Merck & Co. Inc., the Whitehouse Station, N.J., maker of Vioxx, so far faces 4,951 lawsuits in connection with its arthritis painkiller, which the company pulled from the market nearly a year ago.

The first trial resulted in a $253 million award to the plaintiff, and lawyers this week predicted that the Food and Drug Administration, which handles pharmaceutical approvals, will tighten its regulations and require companies to conduct more research after bringing drugs to market.

Corporate lawyers say they are concerned that the thousands of lawsuits will pressure manufacturers to "overwarn" patients about the risks of drugs.

Drug companies may restrict patient access to "lifesaving" drugs out of fear of lawsuits, defense lawyer Dan Troy said at a seminar in Washington Wednesday.

Mr. Troy, with Sidley Austin Brown & Wood LLP of Chicago, has worked with Merck but now represents the company's New York competitor, Pfizer Inc.

Trial lawyer Evan Schaeffer, who is representing 1,000 plaintiffs against Merck, said at the same seminar that the Vioxx cases will prompt drug companies to more fully disclose the risks of their products, which could prevent patient deaths.

"If Merck had been forthcoming about Vioxx and did a true clinical trial on the cardiovascular risks, the drug might still be on the market for a limited number of consumers," said Mr. Schaeffer, who is with Schaeffer & Lamere PC, a Godfrey, Ill., personal injury law firm.

Merck withdrew Vioxx Sept. 30 after a company report found the drug increased the risk of heart attacks and strokes in patients who took it for 18 months or longer.

Merck's defense team failed to persuade the court to delay proceedings for 45 days. The team said in court papers that the Texas verdict last month had created an "unfair prejudice" against the company.

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