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.”


Woodside argues:


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.)


Woodside makes a passionate argument for “why courts should favor the disclosure of research data and address confidentiality concerns using a protective order.” Beck, also a lawyer for manufacturers of pharmaceutical and medical devices, hits the nail on the head:


The article’s legal recommendation – that attorneys faced with such expert opinions in litigation be able to obtain the data that supposedly supports the conclusions – is something of a two-edged sword. If we can do it (subpoena underlying raw research data) to their experts and their experts’ sources, then the other side can do it to us.


Indeed. Beck, however, concludes:


Overall, however, since plaintiffs are already seeking, and often receiving, access to our client’s internal clinical trial databases, we probably have more to gain from the demise of any “researcher’s privilege” than we would lose. While all statistical studies have their flaws, we believe that those we rely upon are far more scientifically valid than what the other side has to offer. Full access to the other side’s data (where they have any) should allow us to prove that.


I suppose it’s a testament to zeal with which we advocate our clients’ respective causes that I – as an attorney who represents plaintiffs – believe exactly the opposite! If I wasn’t bound by confidentiality orders in various drug and device cases that I’m involved in, I could rattle off dozens of examples of published scientific studies relied upon by the defense that I would love to subpoena and see under the microscope. I pick the cases I’m involved in carefully, and I require my experts to support the literature they rely upon. I have no qualms about the research that I use being subjected to scrutiny. I am also quite confident that, if given free reign to wade through the data used by the defendants, I would find more than a few instances of cherry-picking and manipulation.


But, let’s step back for a moment and consider the bigger picture: there are good and sound reasons to keep litigants from being able to pry into scientific data at will.


Woodside is correct that there’s no clear legal basis for a “researcher’s privilege:”


The existence of a researchers’ privilege, however, violates the principle that “the public has a right to every person’s evidence, absent a valid claim of constitutional, common law, or statutory privilege.” Currently, neither the common law nor any explicit federal or state statute protects research data. Despite some ambiguity in case law, the Constitution offers no justification for withholding research data; indeed, the Supreme Court has even denied the existence of an “academic privilege.” Simply put, given the absence of a common law or statutory researchers’ privilege, the public has a right to a researcher’s data when such data is at issue in a lawsuit.


From what I’ve seen, “academic privilege” isn’t usually the reason why third-party research data generally doesn’t come into litigation. Rather, courts tend to worry about the “burden” that responding to a subpoena would impose on the researchers and the “chilling effect” of allowing discovery into research. See, e.g., In re Fosamax Products Liab. Litig., 2009 WL 2395899 (S.D.N.Y. Aug. 4, 2009)(quashing subpoena for deposition of research who participated in a drug safety report issued by the National Academy of Sciences).


And the courts are right to worry.


When it comes to pharmaceutical and medical device litigation, the published scientific literature tends to come in two forms: (1) articles produced by researchers entirely independent of the litigation and (2) articles produced by researchers financially supported by the defendants. (Woodside’s article gives just one example of plaintiffs’ lawyers funding published literature, which happened in Britain.) I don’t think it’s a stretch to conclude that, in general, the independent research is more reliable while the manufacturer-supported research is more prone to bias — in fact, research has shown that happens constantly in the pharmaceutical field. (More examples here.)


Therein lies the rub. Scientists already in the pocket of big pharmaceutical or medical device or chemical companies need not worry about a subpoena from plaintiffs’ lawyers: they can be confident that the deep pockets will rush to their defense against the subpoena, will assist them in responding to the subpoena (if so needed), and will handsomely reward them with future grants and “honoraria” and “consulting” and “advisory board” payments.


Independent scientists, however, have every reason to worry about their academic freedom and their livelihood when they publish results that go against the billion-dollar juggernauts in the medical field. For-profit companies fund the lion’s share of medical research, and so any researcher who wants to publish a study that questions the efficacy or safety of a medical device or drug already has to worry about biting the hand that feeds. Adding in fears about expensive, time-intensive subpoenas and depositions will further increase the “chilling effect” that already exists in the minds of scientific researchers, thereby further inhibiting independent, unbiased researchers from sharing their research.


These concerns are genuine; however, I agree with Woodside that there shouldn’t be a blanket privilege on academic research data. I propose that courts apply a standard that assesses the source of the research before deciding whether to enforce a subpoena for third-party research, generally resulting in fewer enforced subpoenas against independent researchers. The chilling effect on independent researchers is very real, while the chilling effect on paid shills for pharmaceutical, medical device, and biotechnology companies is nonexistent.