Sunday, August 21, 2005

Merck Loses Its First Vioxx Case

It would have been hard to miss the news that the first trial of a civil suit against Merck that claimed patient injuries due to the now withdrawn drug Vioxx yielded a huge verdict for the plaintiff ($24.5 million) , and an immense punitive damages award ($229 million) against Merck. (See the NY Times version here.)
Although Texas law will cap the amount of punitive damages that can be awarded, and many will just dismiss these results as another case of a jury awarding outsized damages to a sympathetic plaintiff, I think there is another message here.
Several news accounts told of the jurors' strong feelings about Merck's conduct:
  • From the Times article above, summarized, as "jurors said they had made the large punitive award to send a message that drug makers must disclose the risks of their medicines. 'Respect us, that's the message,' said Derrick Chizer, a juror."
  • In a Houston Chronicle article, "A majority of jurors said Merck's aggressive marketing of Vioxx led to their decision." Chizer was again quoted, "marketing was a big part of the case." "'It's not the money,' added Marsha Robbins, 53, of Freeport, who served as the presiding juror. 'It's accountability.'" "Chizer said the message jurors wanted to send to Merck was for the company to take their responsibility seriously. 'Every life counts to us. They should be responsible. If they care, then show it.'"
A NY Times news analysis attributed the verdict to "bad facts," i.e., that the plaintiff's attorneys made a convincing case that Merck knew that Vioxx had cardiovascular risks, but then concealed these risks from the public.
The documents showed that scientists at Merck were worried about Vioxx's potential cardiovascular risks as early as 1997, two years before Merck began selling the drug. 'The possibility of increased C.V. events is of great concern,' Dr. Alice Reicin, a Merck scientist, wrote in a 1997 e-mail message. 'C.V. events' is scientific shorthad for cardiovascular problems like strokes or heart attacks. 'I just can't wait to be the one to present this to senior management,' Dr. Reicin's message continued.
The documents also revealed that Dr. Edward M. Scolnick, who at the time was Merck's top scientist, said in March 2000 that the largest clinical trial ever conducted of Vioxx confirmed that Vioxx had heart attack risks, as he had feared. They showed Dr. Scolnick later referring to scientists at the Food and Drug Administration as untrustworthy. And they revealed that Merck had stridently resisted the F.D.A.'s efforts to add warnings to Vioxx's label, and that it eventually complied only in ways that the Texas jury found unacceptably obscure.
Mr. Lanier [the plaintiff's attorney] also introduced a marketing videotape that showed Merck sales representatives being trained to view doctors' concerns about Vioxx's heart risks as 'obstacles' to be avoided, or dismissed. Another marketing document taught representatives to play 'Dodgeball' when doctors voiced concerns.
So the jury concluded that Merck's leadership deliberately suppressed information about its drug's adverse effects, over the objections of its scientists, thus putting marketing ahead of patients' welfare.
Thus the Vioxx case becomes another sorry example of how leaders of major health care organizations may threaten health professionals' core values.

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