Gerald Barnett received $50 million in "compensatory" damages, with the jury to return to the question of punitive damages. Barnett had high blood cholesterol, a family history of cardiac problems, and documented cardiovascular disease before he ever took Vioxx. The verdict, if reduced to judgment, will set up a defense challenge to Judge Fallon's questionable Daubert rulings, which we noted on Nov. 23. Merck has won seven out of eleven cases so far, and five out of nine trials—at least, that was the score before Judge Higbee's bombshell today. (Heather Won Tesoriero, "Merck Failed to Warn Doctors About Vioxx's Risk, Jury Says", Wall Street Journal, Aug. 17).
Update, 1:42 PM. The jury awards $1 million in punitive damages. (More Point of Law coverage on the Barnett case.) In addition, Peter Lattman is reporting that Judge Higbee (with remarkably coincidental timing) has ordered a new trial in the Humeston case that Merck won last year (Nov. 3, Nov. 4). Readers will recall that we have been skeptical of the claims that Judge Higbee's courtroom in New Jersey provides Merck with "home court advantage" (e.g., Apr. 6, Oct. 7).
Update, 3:49 PM: Forbes' Matthew Herper is reporting that Higbee's decision was based on NEJM's editorials, which we discussed on Feb. 22, Feb. 27, Jun. 28, Feb. 14; Jan. 8; Dec. 16; Dec. 10; and Dec. 8. (Update to the update: Peter Lattman excerpts from the ruling, which appears to come from the bench.)
One thing we haven't yet mentioned about the NEJM editorial was the Wall Street Journal May 15 expose confirming our earlier suspicion that the timing and content of the editorial was politically, rather than scientifically, motivated:
A public-relations specialist who has advised the journal since 2002 predicted the rebuke would divert attention to Merck and induce the media to ignore the New England Journal of Medicine's own role in aiding Vioxx sales.
"I believe that given what a public punching bag Merck has become, there is more than enough information and more than enough context in the statement to drive the media away from NEJM and toward the authors, Merck and plaintiff attorneys," wrote Edward Cafasso, a Boston-based public relations consultant, in a late-night email to journal staffers hours before the expression was released. ...
Perhaps the most sensational allegation in the journal's expression of concern was that the authors of the November 2000 article deleted heart-related safety data from a draft just two days before submitting it to the journal for publication. The journal said it was able to detect this by examining a computer disk submitted with the manuscript.
The statement was ambiguous about what data the authors deleted, hinting that serious scientific misconduct was involved. "Taken together, these inaccuracies and deletions call into question the integrity of the data," the editors wrote.
In reality, the last-minute changes to the manuscript were less significant. One of the "deleted" items was a blank table that never had any data in it in article manuscripts. Also deleted was the number of heart attacks suffered by Vioxx users in the trial -- 17. However, in place of the number the authors inserted the percentage of patients who suffered heart attacks. Using that percentage (0.4%) and the total number of Vioxx users given in the article (4,047), any reader could roughly calculate the heart-attack number.
Dr. Curfman says it would have been easier on readers to give the exact number and admits "both the authors and the editors slipped up" in not including it.
Many news organizations, including The Wall Street Journal, misunderstood the ambiguous language and incorrectly reported that the deleted data were the extra three heart attacks -- which, if true, would have reflected badly on Merck. The New England Journal says it didn't attempt to have these mistakes corrected. Dr. Curfman says the language about the deletions is "very precise and it is correct."
The day after the expression of concern, Mr. Cafasso emailed colleagues: "The story is playing out exceptionally well."