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Merck Faces U.S. Investigation Regarding Its Painkiller Vioxx

By Andrew Pollack

The New York Times -- NEW YORK

Federal prosecutors and the Securities and Exchange Commission are investigating Merck & Co. in connection with Vioxx, the painkiller that was pulled from the market in late September because it increased the risk of heart attacks in long-term users.

Merck said on Monday that it had received a subpoena from the Justice Department “requesting information related to the company’s research, marketing and selling activities with respect to Vioxx.” It said the request related to a “federal health care investigation under criminal statutes.”

Merck, which disclosed the investigations in its quarterly filing with securities regulators, said that the staff of the SEC had told the company that it had begun an informal inquiry.

Merck did not say what the investigations were about and federal agencies do not as a rule comment on such investigations. But since the Vioxx withdrawal, questions have swirled about whether Merck knew the risks of Vioxx several years ago but had covered them up. For years, even as evidence mounted that the medicine might increase the risk of heart attacks, Merck disputed such findings.

A spokesman for Merck said on Monday that the company “acted appropriately and responsibly in our development and marketing of Vioxx” and would cooperate with the investigation.

One possibility is that the SEC is looking into whether Merck misled shareholders about the safety of Vioxx. The Justice Department investigation could be looking at that issue as well as whether Merck misled regulators or perhaps caused Medicare to pay for the prescription drug when its use was not warranted. The investigations are in addition to hundreds of lawsuits Merck is facing from people claiming to have been injured by Vioxx and lawsuits from shareholders claiming the company’s management misled investors.