Photograph of a prescription bottle that reads "May cause dizziness" next to a piece of paper that reads "Side Effects"

Court Secrecy in Drug Product Liability Cases

By Phebe Hong

Protective orders, confidentiality agreements, and sealed court files significantly impair public access to vitally important records. Recent news coverage highlighting two high-profile drug product liability cases are ongoing examples of how our court system prevents crucial public health information from reaching the public domain.

Two Cases, Many Secrets

On September 11, 2019, Reuters released an article on the multidistrict litigation against Merck for sexual and mental problems caused by its hair loss drug, Propecia. More than 1,100 patients filed against Merck for not adequately warning patients of Propecia’s possible side effects, though the majority of patients later settled with the company.

Reuters noted that many of the court documents associated with the suit were heavily redacted or filed under seal. Reuters criticized the presiding judge in the case for “allow[ing] the medical secrets contained in the documents to be kept out of public view” and “without explanation, allow[ing] Merck and plaintiffs’ lawyers to keep information submitted in court confidential.” Due to faulty redactions and filing errors, Reuters was still able to obtain and report confidential information from the documents, including the fact that Merck knowingly underreported the number of men who experienced sexual side effects during an extended study of Propecia. The Propecia litigation demonstrates how court secrecy can prevent dissemination of important public health information.

Similarly, on September 12, 2019, the American Medicine and Public Health Historians and the Organization of American Historians filed a brief with the Ohio district court requesting for “full and permanent access to the records” related to settlements in the ongoing massive opioid litigation. The group of historians expressed fears that opioid companies would bargain to keep important documents under seal as part of settlement negotiations. The scholars argue that the documents, including internal company communication, reports, and databases, could be useful for public health research, and thus advocate for their availability through a public website. The brief is an effort to combat the growing use of confidential agreements to keep drug information secret.

Court-Sanctioned Secrecy

Trial courts generally have broad discretion over discovery matters, including protective orders and secrecy agreements. In most states, judges are supposed to weigh a request for redaction or secrecy against the public interest in making the evidence public. In practice, however, as a study by Reuters revealed, judges provide no explanation for allowing secrecy in 85% of cases in which health and safety information was kept under seal. Secrecy has become an accepted practice in our court system.

Protective orders and confidentiality agreements were intended to protect the privacy and business interests of litigants and third parties. In the context of drug product liability cases, however, they often prevent crucial health information from being disseminated to the public. Regulatory agencies and patient organizations often depend on the judicial system to learn about health and safety hazards. The growing use of court-sanctioned secret settlements and protective orders in product liability cases, therefore, poses risk to overall public health and safety, by denying the public access to the information and hampering the ability of parties to take legal action against bad actors. As the two recent cases highlight, efforts are still needed to reduce secrecy in our court system.

Phebe Hong

Phebe Hong

Phebe Hong is a 2L at Harvard Law School. She graduated from Harvard College with a degree in Human Developmental and Regenerative Biology. Prior to law school, she worked as a consultant advising pharmaceutical and biotechnology companies. She is a Research Assistant at the Program on Regulation, Therapeutics, and Law (PORTAL) and an Articles Editor for the Journal of Law and Technology. Her research interests include FDA regulation of biologics and pharmaceutical patent law.

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