Over at Drug and Device Law, Jim Beck highlights a new law review article, “Researchers’ Privilege: Full Disclosure,” published by Dr. Frank Woodside, described by the article as “of counsel to the law firm of Dinsmore & Shohl and [ ] a nationally known trial lawyer representing manufacturers of pharmaceutical and medical devices, chemicals, and flavorings, as well as producers of consumer products.”
Sometimes the authors of published studies or counsel relying on these researchers’ work have attempted to place barriers in the way of academicians or counsel who wish to challenge the validity of the published studies and their underlying data. These barriers originate from a misunderstanding, or misuse, of the concept of academic freedom—a litigation strategy that asserts the existence of the so-called “researchers’ privilege,” also known as “academic privilege,” “academic freedom privilege,” or “the research scholar’s privilege”—as well as the improper application of the Freedom of Information Act (“FOIA”). These challenges create a legal environment where opinions based on the published results of flawed research are admitted into evidence without providing opposing parties the opportunity to develop the facts necessary to assess the opinion’s validity. This admission of uninvestigated evidence creates the potential for unjust results.
Although published literature plays a big role in large-scale litigation these days, subpoenas against third-party researchers have generally fared poorly in the courts. One of the few successful examples I know of involves the Prempro products liability litigation, where Wyeth was able to compel the Women’s Health Initiative to turn over hormone treatment assignments and trial data collected. (In case anyone is wondering how that issue turned out, although Wyeth continues to fight these cases in the courts, there is a scientific consensus that hormone therapy increases the risk of breast cancer.)