SAN FRANCISCO (Reuters) - Reuters asked a U.S. judge on Thursday to unseal documents filed in court regarding potential risks associated with Propecia, Merck & Co's MRK.N popular baldness drug.
The motion was filed in federal court in Brooklyn, New York, after a Reuters article on Wednesday revealed accusations that Merck did not fully disclose on Propecia’s label the incidence and duration of sexual dysfunction in men who took Propecia in clinical trials. Those allegations are contained in court filings that had been intended to be filed under seal.
Federal District Judge Brian Cogan has allowed Merck to keep secret internal company documents in litigation brought by Propecia users against the company. A faulty redaction allowed Reuters to view some of the details in a plaintiff’s brief, but the underlying Merck documents cited in that brief are still sealed. Those are the documents the Reuters motion seeks to make public.
“This is a case of tremendous importance that has been sealed without on-the-record findings explaining that sealing,” Reuters argued in its motion to intervene in the case. “The First Amendment precludes such an outcome.”
Merck did not respond to a request for comment. The company previously told Reuters it “stands behind the safety and efficacy of Propecia” and noted that the drug has been prescribed safely to millions of men since the late 1990s.
A June 25 Reuters investigation revealed how judges have allowed the makers of dozens 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 over the past couple of 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 under seal.
More than 1,100 Propecia-related lawsuits filed across the U.S. against Merck were consolidated before Judge Cogan in so-called multidistrict litigation (MDL). Merck agreed to settle most of them last year 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 allegation in court.
Under U.S. law, court filings are presumed to be public, and the bar for secrecy is particularly high for the Propecia documents Reuters seeks to unseal, the motion states, because they are essential to plaintiffs’ claim that the drug causes persistent sexual side effects.
“These documents should not remain under seal absent the most compelling reasons,” Reuters argued.
Reporting by Dan Levine
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