Tuesday, March 1, 2022


MFIA Succeeds in Lifting Speech Restrictions on Yale Medical Expert

Detail of courtyard archway at Sterling Law Building

The Media Freedom and Information Access Clinic (MFIA) at Yale Law School has succeeded in lifting speech restrictions imposed on a leading cardiologist and public health expert by the producer of a defective medical device — freeing him to share information and conduct research with public health implications.

Yale cardiologist Harlan Krumholz was an expert witness in a 2014 medical products liability case against Cook Medical, Inc., the producer of an intravenous filter sold under the trade name Celect. As a witness, Krumholz had access to the company’s nonpublic research and documents related to the device. But a stipulated protective order Cook required to Krumholz to sign barred him from sharing that information with anyone outside of the lawsuit, including federal regulators. Krumholz, believing the information he learned was of vital public interest, sought release from these restrictions. MFIA took up the fight in 2020. 

This February, after a lengthy negotiation prolonged by the COVID-19 pandemic, MFIA obtained a revised order from Cook that allows Krumholz to research, share, and report on the company’s data. 

“I believe this to be a case study that indicates many vulnerabilities in our current approach to regulating devices,” Krumholz said. “Having a better understanding of what happened here could help save lives in the future.” 

MFIA’s efforts to release Krumholz from the confidentiality requirements grew out of its work with the Collaboration on Research Integrity and Transparency (CRIT), a joint project of Yale’s schools of law, medicine, and public health dedicated to improving the integrity and transparency of clinical research. MFIA’s work with CRIT sought to illuminate the larger harms to the public that result from the routine sealing of such court documents. Reuters and other news agencies have reported on ways that standard protective orders prevent the public from learning important public health information regularly developed through litigation.  

The Cook case began when Tonya Brand sued the company in federal court after her Celect filter fractured inside her, causing injury. Krumholz’s focus as an expert witness was on understanding the practices that led to the authorization of the defective device, which was eventually withdrawn from the market. As an expert witness, he was given access to documents from Cook concerning the design, manufacture, and clinical testing of the device, along with communications with the FDA and internal discussions about the filter. 

Before gaining access to Cook’s documents during the discovery phase of the case, Krumholz was compelled to sign a blanket protective order that prohibited him from using any information that Cook considered confidential outside of the litigation. This routine requirement is supposed to protect legitimate trade secrets, but companies regularly designate almost all documents produced in discovery as “confidential,” whether they contain legitimate trade secrets or not. 

In signing the Cook protective order, Krumholz was under the impression that the considerable information eventually presented at trial would be considered in the public domain. That information could then be used for medical and public health research, where quality data on IVC filters are rare. But Cook took the position that Krumholz’s confidentiality obligation continued past the trial and prevented his discussion of information whether it had been disclosed publicly in the court proceedings or not. Krumholz challenged Cooks’ position because he believed he had a moral and ethical obligation to let the public know what he had learned in reviewing the Cook data.

Agreeing to work with Krumholz, MFIA prepared a motion before the pandemic hit in 2020. This motion contended that the gag on Krumholz restricted his First Amendment rights without adequate justification. Where a substantial public interest exists in knowing information contained in documents produced in discovery, MFIA argued, more than a routine desire to protect a litigant’s privacy must be shown to justify the restriction on free speech rights. 

Cook ultimately opted to release Krumholz from most restrictions in the protective order, without a court order forcing the release. After extended negotiations, Cook eventually agreed to remove its confidential designations on all documents provided to Krumholz, except for certain internal Cook emails that did not contain data and did not go to the FDA. Krumholz is now developing research projects that will ultimately share this information with the public. The settlement with Cook limits Krumholz only to his agreement to use information “in the public interest” and not for a commercial purpose. 

“The suppression of important information through protective orders is disturbing part of civil litigation today, where courts routinely enter broad protective orders without any inquiry into the need for protection and little judicial oversight of the discovery process,” said MFIA clinic director and Floyd Abrams Clinic Lecturer in Law David Schulz ’78. “This is a case of upholding the public’s right to know health and safety information generated through the process of civil litigation, an important tool for holding powerful interests accountable.”

MFIA students who worked on the case include Eli Feasley ’21, James Fitch ’21, Sean Foley ’21, Zoe Rubin ’22, Sara Sampoli ’21, and Katherine Surma ’21.

The Media Freedom and Information Access Clinic is dedicated to increasing government transparency, defending the essential work of news gatherers, and protecting freedom of expression through impact litigation, direct legal services, and policy work.

By Mila Samdub