Confidentiality in Drug and Medical Device Litigation

A new article over at JAMA Internal Medicine by a group of distinguished scholars in law and medicine is drawing welcome attention to the ways in which “important public health information that emerges during medical product liability cases is commonly kept confidential.”

Protective orders often prevent parties from disclosing troubling evidence of corporate misdeeds. Courts will frequently seal records at the parties’ request, even when those records are relevant to the public health. And most settlements contain confidentiality agreements, shielding their terms from public view.

An example comes from a wave of lawsuits filed against Wyeth  Pharmaceuticals in 2002 after data emerged from 2 studies that the company’s estrogen hormone therapy (Prempro) increased the risk of heart disease, stroke, and breast cancer among postmenopausal women. During discovery, Wyeth Pharmaceuticals produced internal documents detailing a marketing strategy in which the company had hired medical communication companies to ghostwrite dozens of articles promoting unproven benefits of estrogen replacement and downplaying the risk of breast cancer. Pursuant to a blanket protective order entered in July 2005, Wyeth Pharmaceuticals designated all of these documents confidential, which prevented plaintiffs, attorneys, and experts from sharing the information to the general public and even the FDA. The documents would have remained confidential, but in 2009 plaintiffs along with the medical journal PLOS Medicine and The New York Times (as third parties) successfully petitioned the court to lift the protective order by showing that the documents did not qualify as confidential under Rule 26(c). The documents were subsequently used for newspaper and research articles describing how Wyeth Pharmaceuticals distorted the medical literature, overtly characterizing hormone therapy as safe and effective, and contributed to its widespread use among millions of women who had no medical indication for the drug.

The authors recommend a number of steps to lift the veil of secrecy:

Given the various factors that encourage the current secrecy practices, protecting the public’s interest in the information revealed in medical product litigation presents a challenge and will require efforts from attorneys, experts, judges, and legislators. While progress might be made via new legislation or rules that impose greater burdens on parties seeking to prevent disclosure of information, existing legal requirements for confidentiality, if properly enforced and interpreted, can also do much more to protect the public interest.

All of this seems perfectly sensible to me, but it may not go far enough. My friend Glenn Cohen and I wrote up a commentary on the article raising questions about whether litigants and judges would be likely to take up the authors’ recommendations.

Contrary to what is depicted on television, almost all civil litigation ends in settlement, not a trial. In settlement negotiations, plaintiffs use any incriminating or embarrassing documents obtained during discovery as leverage (“If we go to trial, these will all be public”). As [the authors] acknowledge, companies are willing to pay more to settle a case if it allows them to bury those documents.

Insisting on transparency may therefore reduce a case’s settlement value. That is a problem for plaintiffs. Although many people might wish it were otherwise, many lawyers will only take big, expensive cases on a contingency fee basis if they think they can secure a substantial payout. More transparency could thus yield fewer lawsuits, allowing drug companies and medical device manufacturers to act with more impunity, not less. In addition, if such documents are routinely made available to the public, potential plaintiffs may adopt a wait-and-see approach. Why do all the hard work of discovery if every follow-on plaintiff gets to see all the defendant’s records for free? * * *

It is also worth considering whether the authors’ arguments against the status quo can be neatly confined to pharmaceutical or medical device litigation. For example, the #MeToo movement has galvanized a similar line of criticism against confidential settlements in connection with workplace harassment. If it is in the public interest to share documents from drug and medical device companies, why is it not also in the public interest to demand disclosure in connection with malpractice litigation against physicians or hospitals? Or really any individual or institution that is alleged to have harmed some member of the public?

From our perspective, “more ambitious interventions (perhaps not directed at the courts at all) may be needed” to combat the problem of secrecy in drug and medical device litigation.


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