Patent Law

Court shields peer review documents from disclosure

By Lawrence B. Ebert, Esq.

In a decision likely to be welcomed by editors everywhere, a federal judge in Chicago today [March 14] denied a drug company's efforts to obtain confidential peer-review documents from a major medical journal. Although journals have successfully fended off such requests before, a loss in this case would have set a troubling precedent for other cases, including a similar suit pending in Massachusetts.

Pfizer is being sued in a class-action lawsuit in a northern California federal court by patients who took the arthritis drugs Bextra and Celebrex, which have been linked to heart attacks and other problems. In January, Pfizer filed a motion asking for peer-review documents it had subpoenaed from 11 studies on the drugs published by the New England Journal of Medicine (NEJM). Pfizer, which also wanted rejected studies, said that manuscripts might contain data that could be useful for its defense. NEJM argued that releasing the information would compromise peer review, which is supposed to be anonymous, a position supported in an affidavit by the editor-in-chief of Science, Donald Kennedy (Science, 22 February, p. 1009). Pfizer also filed a motion seeking peer reviews from the Journal of the American Medical Association (JAMA) and the Archives of Internal Medicine, which had published 11 studies on the drugs.

In an affidavit filed on 29 February, JAMA Editor-in-Chief Catherine DeAngelis argued that if the court granted the motion, similar subpoenas could become routine, which could result in a "severe decline" in the number of peer reviewers and affect the journal's ability "to properly discharge its mission to advance the betterment of public health."

Today, the U.S. District Court for the Northern District of Illinois agreed with DeAngelis. "Although her statements are quite dramatic, it is not unreasonable to believe that compelling production of peer review documents would compromise the process," wrote Magistrate Judge Arlander Keys. The court also found that Pfizer had not adequately explained how the confidential peer reviews could help it defend itself in the lawsuit. Given the lack of relevance, the court found that "whatever probative value the subpoenaed documents and information may have is outweighed by the burden and harm that would result" to the journals.

DeAngelis was not available for comment, but a JAMA spokesperson said the journal was pleased with the judge's ruling. The U.S. District Court in Massachusetts held a hearing yesterday on NEJM's efforts to block the Pfizer subpoena. That decision could come within the next 2 weeks or so, says Paul Shaw of Brown Rudnick Berlack Israels LLP in Boston, which is representing NEJM.

Derek Lowenoted:

At least I think it does - I assume that Pfizer wants names attached to these things, unless they can use them in their case without attribution. Even so, that still doesn't sound like something that'll make people enthusiastic about reviewing such papers - the prospect of having their comments read off in open court. No, I think that argument that sank Pfizer's requests in Illinois still obtains, and that the Massachusetts court will rule the same way.

IPBiz notes that the relevancy to Pfizer is "what was said", not in "who said it." If that is so, one would hope that reviewers would NOT be reluctant to have "their comments read off in open court."

Full post as published by IPBiz on March 21, 2008 (boomark / email).