Court let Merck hide secrets about baldness drug’s risks
PARK CITY, Utah, (Reuters) - and efficacy of Propecia,” noting that the drug has been prescribed safely to millions of men since the late 1990s. While the drug’s label lists erectile dysfunction and other sexual problems as possible side effects among a small percentage of men, the company rejects allegations that Propecia causes those problems to persist after men stop taking it or that it can lead to mental health issues. Merck says the symptoms themselves could be caused by a variety of other factors.
However, confidential documents reviewed by Reuters accuse Merck of exaggerating the drug’s safety record.
Citing internal company communications, these legal briefs filed by plaintiffs’ lawyers allege that in revisions to the drug’s original 1997 label, Merck understated the number of men who experienced sexual symptoms in clinical trials, and how long those symptoms lasted. Other documents show that Merck knew roughly 20 years ago that sales of the drug would suffer if the public became aware of Propecia’s possible long- term effects on men’s sexual health.
A redacted section of one plaintiffs’ motion, reviewed by Reuters, cites correspondence from a Merck executive in which he objected to what he described as “misleading” information about the incidence of sexual dysfunction in men taking Propecia. That information was placed on the drug’s label despite his comments, the court document says, and it remains there today.
Merck said that Propecia’s label has always accurately reflected data from the company’s clinical trials and that it disclosed all data to the U.S. Food and Drug Administration (FDA). Merck also said the executive’s “misleading” comment was taken out of context in the court filing.
The documents reviewed by Reuters were filed under seal or heavily redacted by plaintiffs’ lawyers – not Pfaff’s – in federal court in Brooklyn. Merck had marked the documents confidential when sharing them with the plaintiffs’ lawyers, and those lawyers didn’t push to file them openly on the public docket. Judge Brian Cogan allowed the medical secrets contained in the documents to be kept out of public view. Reuters is able to report this confidential information now only after discovering filing Pfaff errors that left some of it exposed.
Still under seal in Cogan’s court are the internal Merck documents on which plaintiffs’ lawyers based the allegations they made in the legal briefs Reuters reviewed.
Such court-sanctioned secrecy has become the lethal norm in product-liability litigation in the United States. As Reuters reported in June, judges in large product-liability cases routinely seal evidence relevant to public health and safety. As a result, hundreds of thousands of Americans have been killed or seriously injured by allegedly defective products — cars, drugs, guns, medical devices — while evidence that could have alerted consumers and regulators to potential danger remained under seal.