Buffalo transparency clinic wins access to local jails’ records on suicide attempts

The University at Buffalo School of Law Civil Liberties and Transparency Clinic, a Free Expression Legal Network member, successfully sued the Erie County Sheriff recently on behalf of the National Lawyers Guild Buffalo Chapter for access to the records of Buffalo’s local jails concerning suicide attempts by inmates.

The resulting records revealed that the sheriff, who runs the county’s jails, mischaracterized suicide attempts in the jails as “inmate disturbances” or “manipulative gestures.” This means that the jails failed to properly report suicide attempts to the state’s oversight commission, and the National Lawyers Guild argues it could frustrate attempts to prevent future suicides.

The clinic and the National Lawyers Guild won a near complete victory in the litigation, brought under New York’s Freedom of Information Law, in the trial court last fall. Among other things, the Court ordered the jail to turn over reports documenting incidents in the jails, internal policies and procedures, and relevant emails. As a result of the sheriff’s refusal to voluntarily release any documents, the clinic also won $27,000 in attorney’s fees.

The Sheriff’s Office has paid the attorney’s fees and produced many of the documents that were ordered released. It is appealing the lower court’s ruling, however, with respect to any emails.

The National Lawyers Guild argues that this appeal prevents it and the public from determining the full scope of the mischaracterization of suicide attempts in Buffalo’s jails. This issue is especially urgent because there has been a string of more than two dozen suicide deaths at the local jails in recent years, as The Buffalo News has written. More broadly, the jails have been cited as among the “worst offenders” for violations of state law by the state oversight commission.

A local reporter, Matt Spina, has covered the local jails for years. He assisted in this litigation by providing background on the jails’ past records practices and explaining the importance of the documents to the court. In an affidavit, Spina noted that it is “difficult or impossible to properly report stories” concerning local jails without the types of documents this lawsuit uncovered. The Buffalo News continues to publish stories about the litigation and also wrote an editorial strongly supporting the lawsuit and condemning the sheriff for appealing the order.

The clinic continues to represent the National Lawyers Guild in the appeal.

Clinics help transparency advocates win victory for public access to clinical trial data

Note: A version of this post originally appeared on Yale Law School’s website.

ruling from a federal judge on February 24, 2020, will dramatically expand the public’s right to access results of clinical trials studying drugs and medical devices. The ruling is the latest development in a lawsuit brought by the Yale Media Freedom and Information Access (MFIA) and NYU Technology Law & Policy (TLP) Clinics on behalf of Charles Seife and Dr. Peter Lurie, with the support of the Yale Collaboration for Research Integrity and Transparency (CRIT).

Judge Naomi Reice Buchwald of the Southern District of New York held that the Food and Drug Administration (FDA), National Institutes of Health (NIH), and Department of Health and Human Services (HHS) have misinterpreted a 2007 law that requires drug companies, universities, and other sponsors of clinical trials to disclose the results of clinical trials of FDA-approved products to the public via the ClinicalTrials.gov website.

The court’s order requires the government to collect and post about a decade’s worth of trial results that should be public under the 2007 law — making data from potentially hundreds of clinical trials available for the first time. “This is an extraordinary victory for patients and clinical trial researchers,” said Joseph Ross, Professor of Medicine and Public Health and faculty co-director of Yale CRIT. “The government now has a clear legal obligation to enforce these reporting requirements, and by doing so it will promote more fully-informed decision-making by patients and their clinicians.”  

Background on ClinicalTrials.gov and the need for clinical trial data

High-quality medical care requires high-quality evidence. But sponsors of clinical trials that investigate the safety and efficacy of medical products don’t always publish their results where doctors and patients can find them, according to the clinic. Instead, sponsors may “cherry-pick” data by publishing favorable clinical trial results and keeping secret unfavorable results.

“Recognizing this problem, Congress enacted the Food and Drug Administration Amendments Act (FDAAA) to ensure a flow of clinical trial evidence to patients, clinicians, and researchers through the public ClinicalTrials.gov website,” said Christopher Morten, supervising attorney at the TLP Clinic. “Yet NIH and HHS promulgated a rule and an interpretation of FDAAA that created an illegal ‘loophole.’” As MFIA student Simon Brewer explained, “the loophole purported to exempt many clinical trials of FDA-approved products completed between 2007 and 2017 from any obligation to ever report their results to ClinicalTrials.gov.” 

Seife emphasized the importance of the law: “The FDA is in charge of making sure that drugs on the market are safe and effective, but without access to data about those drugs, it’s nearly impossible to understand whether the agency is doing its job properly. ClinicalTrials.gov is a key source of this data.”

The MFIA-TLP lawsuit on behalf of Seife and Lurie

Seife and Lurie are two leading researchers on clinical trials whose research has been hindered by the absence of information on ClinicalTrials.gov. Seife is an investigative journalist at NYU whose work focuses on science and technology. Lurie is a family physician, president of the Center for Science in the Public Interest, and a former associate commissioner of the FDA.

In December 2018, MFIA filed suit on Seife and Lurie’s behalf. The suit sought to close the loophole and requested a declaration that NIH’s and HHS’s interpretation of FDAAA was inconsistent with the statute. Brewer argued Seife and Lurie’s case in court on February 11, 2020.

Judge Buchwald’s decision, issued on February 24, was a victory for Seife and Lurie on their loophole claim. The court concluded that “FDAAA unambiguously requires responsible parties [i.e., trial sponsors] to submit, and defendants to include on ClinicalTrials.gov,” results for loophole trials and therefore that “HHS’s contrary interpretation . . . is unlawful and must be set aside.”

“Judge Buchwald’s decision will help ensure that these government agencies and the drug and device industries are jointly held to account, and that the promise of the clinicaltrials.gov database be finally fulfilled,” said Lurie. “True transparency requires that all results of clinical trials be truthfully reported, be they positive, negative, or somewhere in between — and even in cases where the study sponsors or FDA would prefer not to disclose.”

The court also held that it could not grant relief on a separate claim, which asked for an order requiring NIH to post public notices of noncompliance whenever sponsors fail to submit results. Seife and Lurie are considering a potential appeal of this claim with their legal team.

Besides Brewer and Morten, Seife and Lurie’s legal team also included John Langford ’14, Adam Pan ’18, Jennifer Pinsof, and David Schulz ’78 of MFIA and Jason Schultz of the TLP Clinic. The lawsuit was conceived and supported throughout by CRIT members, including Alex Egilman, Gregg Gonsalves, Amy Kapczynski ’03, Harlan Krumholz, Shweta Kumar, Margaret McCarthy, Jennifer Miller, Joe Ross, and Joshua Wallach, and was further supported by Merith Basey of Universities Allied for Essential Medicines.

MFIA is a student clinic at Yale Law School dedicated to increasing government transparency and advancing the public’s right of access to information. TLP is a student clinic at NYU School of Law focused on issues at the intersection of technology, law, and social justice. The Collaboration for Research Integrity and Transparency (CRIT) is an interdisciplinary initiative launched in 2016 to enhance the quality and transparency of the research base for medical products. CRIT has received funding from Arnold Ventures. The lawsuit does not represent the institutional views of Yale University or NYU.  

Clinic coalition leads effort to limit Supreme Court’s ruling in Food Marketing Institute

The U.S. Supreme Court’s 2019 decision Food Marketing Institute v. Argus Leader (FMI) dramatically changed the landscape of the Freedom of Information Act’s (FOIA) Exemption 4 for “confidential” “commercial or financial” “information.” But a coalition of transparency clinics — led by Cornell Law School’s First Amendment Clinic in tandem with Yale’s Media Freedom & Information Access Clinic as well as co-counsel from Vinson & Elkins’s Tom Leatherbury — is pushing back in a case in the Southern District of New York.

These clinics represent science journalist Charles Seife, who argued in summary judgment papers in September and December in front of Judge Furman that 2016 FOIA amendments limit the scope of the Food Marketing Institute decision, and that even under the Supreme Court’s new test, Seife should prevail in his efforts to obtain critical information related to the efficacy of an important FDA-approved drug.

The coalition argues that the textualist approach employed by the court in FMI applies equally to a new standard, enacted by Congress in 2016, known as the “foreseeable harm” requirement — an issue not considered in FMI, which involved a 2011 FOIA request prior to the effective date of these amendments. This standard requires agencies to reasonably foresee a harm from disclosure of the sought-after information before blocking its release.

In Seife’s case, neither the government (specifically, the FDA and HHS) nor the private intervenor-defendant (a drug company known as Sarepta Therapeutics) meaningfully engaged on the issue of whether there was a finding of foreseeable harm in this case, arguing instead that FMI decided issues related to the foreseeable harm standard even though they were never presented to the Supreme Court.

Seife also makes other important arguments:  That the 2016 amendments baked into FOIA a public interest in “knowing what the government is up to” as well as a rigorous and meaningful standard for the new FMI test that does not simply allow the government to state that information is “confidential” to render it so.

The case is now fully submitted to Judge Furman, and the clinics are awaiting a decision.

“I’m incredibly grateful to the team for fighting so long and hard on this case,” Seife said. “Journalists, especially freelancers, often don’t have the resources to fight in court for information withheld by the government. In this case, however, Yale and Cornell and Vinson & Elkins have made it possible to push for documents that are important for the public to understand not just what the government is doing behind the scenes when it approves drugs, but also crucial to understanding the safety and effectiveness of new medications.”

Read more from the clinics’ filings in the case:

Photo by Joe Ravi is licensed under CC-BY-SA 3.0.

UC Irvine’s IPAT Clinic wins disclosure of child services records

This post originally appeared on the IPAT Clinic’s website on September 16, 2019.

Students from the UCI Intellectual Property, Arts, and Technology Clinic won disclosure of government records earlier this year, revealing how social workers failed to protect a 10-year-old Los Angeles boy from years of alleged physical abuse, eventually ending with his death and murder charges being filed against his mother and her boyfriend.

The clinic’s client, journalist Garrett Therolf, published a lengthy story about the boy, Anthony Avalos, in the Los Angeles Times on September 4 based in part on the documents obtained by UCI students.

Students Cassie Doutt, Shanxi Feng, and Emily Asgari filed a petition with the Los Angeles Superior Court’s juvenile court division in March 2019 on behalf of Therolf, a staff writer at the UC Berkeley Investigative Reporting Program, asking the court to unseal records from the LA Department of Children and Family Services detailing years of alleged abuse of young Anthony.  In July, a judge ordered most of the records unsealed, and Garrett was provided the documents in late August.

The students are part of the IPAT Clinic’s Press Freedom and Transparency practice, headed by UCI Staff Attorney Susan E. Seager, providing pro bono legal services to journalists, documentary filmmakers, and others.

Photo by Mathieu Marquer is licensed under CC BY 2.0

Harvard Cyberlaw Clinic files amicus brief arguing for broader access to government databases

The Harvard Cyberlaw Clinic filed an amicus brief (pdf) in March in the United States Court of Appeals for the Ninth Circuit on behalf of a group of data journalists and media organizations, advocating for a different approach to Freedom of Information Act (FOIA) requests relating to databases. The brief supports the Center for Investigative Reporting in an appeal arising out of a FOIA request submitted by CIR to the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF).

CIR requested data from ATF’s firearm trace database, seeking records about firearms that were originally owned by law enforcement. In its denial of the FOIA request, ATF cited the Tiahrt Amendment, a rider contained in annual appropriations acts from 2003 to 2012. The Tiahrt Amendment prohibits disclosure of firearm trace information in response to FOIA requests, but allows the release of “statistical aggregate data.” Unfortunately, some courts have held that agencies are not required to release aggregate data that they have not already compiled because it constitutes production of a “new record,” which is not required under FOIA.

The lower court ruled in favor of ATF,  finding that CIR’s request would require ATF to create a new record. A Ninth Circuit decision on this case has the potential to shape FOIA jurisprudence relating to databases, which will have wide-reaching effects since more and more records are being stored in database format.

The Cyberlaw Clinic’s amicus brief focused on whether searching, filtering, sorting, and other forms of database manipulation constitute the creation of a new record. Amici explain how databases like the one used by ATF are structured, and how a database can be queried to yield information in various arrangements. While courts have previously analyzed databases as analogues to massive filing cabinets storing thousands of records, amici show that a database is like no filing cabinet that has ever existed. In fact, databases may have more in common with the famed Room of Requirement at Hogwarts than with how documents were stored on paper.

The amici include sixteen individual data journalists and professors of journalism, and five media-related organizations. All of them have a significant interest in a strong right of access to records held in government databases based on their extensive experience with government transparency processes, including FOIA, and with the technical aspects of working with structured data, including databases.

The media-related organizations are:

  • Investigative Reporters and Editors, a grassroots nonprofit organization dedicated to improving the quality of investigative reporting.
  • The Media Law Resource Center, a non-profit professional association for content providers in all media, and for their defense lawyers, providing a wide range of resources on media law and policy issues.
  • MuckRock, a journalism and government transparency non-profit that has helped thousands of requesters around the United States better file, share, and understand Freedom of Information requests.
  • Freedom of the Press Foundation, a non-profit organization that supports and defends public interest journalism focused on transparency and accountability.
  • The Reporters Committee for Freedom of the Press, an unincorporated nonprofit association whose attorneys provide pro bono legal representation, amicus curiae support, and other legal resources to protect First Amendment freedoms and the newsgathering rights of journalists

The individual journalists include Matt Carroll, Meredith Broussard, Dhrumil Mehta, Cheryl Phillips, Dan Keating, Lucia Walinchus, and Zita Arocha.

By focusing on real-world uses of databases, amici show that there is no practical difference between accessing full records from a database and compiling a list of entries. Amici then point out that the content-index distinction has led to murky jurisprudence in the past and continuing to apply this distinction to databases would require arbitrary line-drawing and lead to absurd results. In the database context, almost any presentation of the data is a record that already exists, and agencies should be required to produce records accordingly.

The Cyberlaw Clinic is honored to have represented these amici and hopes the Ninth Circuit Court of Appeals will seriously consider their input. The brief was written by Clinical Instructor Mason Kortz, Clinical Instructional Fellow Kendra Albert, and Spring 2019 clinical students Alena Farber, Ariel Hoffman, and LeHeng Li.

This post originally appeared on the Cyberlaw Clinic’s blog on March 29, 2019. As of August 2019, the case is still pending.