Judge Orders Merck Documents On Anti-Baldness Drug Propecia Unsealed

A U.S. judge granted a Reuters request to unseal Merck & Co documents produced in lawsuits related to its anti-baldness treatment Propecia, finding that the public's right to access outweighed the drug maker's arguments for keeping the information secret.

Plaintiffs suing Merck alleged that the company did not fully disclose on Propecia's label the incidence and duration of sexual dysfunction in men who took the drug in clinical trials. As part of an investigation of the impact of court secrecy on public health and safety, Reuters published an article in 2019 that examined the basis for those allegations, but many internal Merck documents that might have shed further light on the case remained under seal.

Sunday night, 16 months after Reuters filed a motion asking that those documents be unsealed, U.S. Magistrate Judge Peggy Kuo in Brooklyn rejected Merck's position that the public had no right to access its documents filed in court, which the company said contained proprietary information.

Merck's arguments for keeping the documents sealed, Kuo wrote, "are so weak that they would not overcome even a low presumption of access under the common law." As of Monday, the documents were still sealed on the court docket, despite Kuo’s decision.

​

In a statement to Reuters, Merck said it "interacted appropriately and transparently with global regulators, including FDA (the U.S. Food and Drug Administration), and with physicians and consumers about the safety profile of Propecia. None of millions of pages produced by Merck suggest otherwise, including the documents unsealed by the Court." The company previously told Reuters it "stands behind the safety and efficacy of Propecia" and noted that the drug had been prescribed safely to millions of men since the late 1990s.

In its 2019 investigation, titled "Hidden Injustice," Reuters revealed how U.S. judges routinely allow makers of consumer products to file under seal in their courts information that is pertinent to public health and safety. They often do so without explanation, though in most jurisdictions, they are required to provide one.

The investigation found that hundreds of thousands of Americans have been killed or seriously injured in recent decades by allegedly defective products - drugs, cars, medical devices and other products - while evidence that could have alerted consumers and regulators to potential danger remained hidden.

In 2012, more than 1,100 Propecia-related lawsuits filed across the U.S. against Merck were consolidated before Judge Brian Cogan in Brooklyn federal court in so-called multidistrict litigation. Merck in 2018 agreed to settle most of them for $4.3 million, to be divided among the plaintiffs.

Prior to the settlement, plaintiffs' lawyers cited internal company communications to allege that in revisions to the drug's original label, Merck understated the number of men who experienced sexual symptoms in clinical trials and how long those symptoms lasted. Merck settled before responding to the allegations in court, and Cogan allowed many of the Merck documents to remain under seal without conducting any analysis of whether they merited secrecy.

After Reuters filed its September 2019 motion to unseal, Merck argued that the material should not be considered "judicial documents" - which are entitled to a presumed public right of access - in part because the case had already been settled before the allegations were decided.

Kuo, however, ruled that the presumption of public access does not disappear just because a judge never had a chance to rule on a particular motion. "The continuing presumption of access allows the public to see what is going into the sausage factory, even if a particular sausage is never made," Kuo wrote.

The judge ordered that all the documents sought by Reuters be unsealed.

—Dan Levine

Source