Merck Audit Claims Vioxx Execs Acted Responsibly

Merck & Co.’s board of directors said last week that a 20-month investigation funded by the pharmaceutical company found that senior management acted responsibly in developing and marketing its now withdrawn pain reliever Vioxx.

The 1,700-page report, which cost $21 million, contained some minor criticisms of employee actions but concluded that “management acted with integrity and had legitimate reasons for making the decisions that it made, in light of the knowledge available at the time.”

Merck pulled Vioxx off the market two years ago after a study found it doubled patients’ risk of heart attacks and strokes. The company now faces more than 14,200 lawsuits that allege Merck knew Vioxx’s risks and recklessly sold the prescription medication to the public. Only a few cases have gone to trial. So far, Merck has won four lawsuits and lost four.

Merck’s board established a special committee of six outside directors to conduct an independent investigation of the allegations after the drug was withdrawn. It hired John Martin, a former federal judge now with the law firm Debevoise & Plimpton, to investigate. Mark Goodman, a partner who worked on the investigation, said that no members of the team were directly asked if they had any conflicts of interest with Merck, but that their professional ethics would require them to raise such issues.

Martin acknowledged some cynics might consider the report a whitewash because of its favorable conclusions, but pointed to its heft as evidence of independence. He also said the special committee would not have hesitated to take action against the company if it believed there had been misconduct.

This was “not a slipshod inquiry that simply accepted at face value the statements of Merck’s scientists that they believed that Vioxx was a safe drug,” Martin said. More than 150 witnesses were interviewed, including outside scientists who disagreed with some of Merck’s conclusions, he said.

Martin said that Merck acted appropriately and that the Vioxx situation was unavoidable.

Plaintiff attorney Mark Lanier called the report “an absurd, expensive PR (public relations) stunt” and wondered if anyone would consider “a jury independent if I paid them $21 million.” He said it was an attempt to influence Wall Street analysts and potential jury members.

Lanier doubted the report would be used in a trial despite finding some improper conduct among Merck employees because rules of evidence would mean the entire document with its positive conclusion would have to be included.

Ted Mayer, who heads Merck’s outside trial team, declined to speculate on whether lawyers would attempt to use the report at trial although its conclusions mirror the company defense.

In a statement, Merck said the report confirms the company’s position that it never knowingly put patients at risk. It said it had already addressed some of the report’s concerns and is carefully considering others’ criticism to determine appropriate action. The statement wasn’t specific about its criticism or action.

The report criticized some of Merck’s marketing, public relations and response to doctors who raised concerns about Vioxx’s safety.