Propecia (finasteride) is a medication produced by Merck & Co. that is used to treat male pattern baldness (MPB). (A different version of finasteride, Proscar, has been used to treat enlarged prostates since 1992.) The FDA approved Propecia in 1997; it has since been prescribed to over one million men. Propecia has been shown to decrease hair loss in most men after six months of treatment.
Propecia can cause serious and sometimes permanent side effects, including reduced libido, impotence, erectile dysfunction, and ejaculation disorders.
Unfortunately, Propecia also causes serious and sometimes permanent side effects, including reduced libido, impotence, erectile dysfunction, and ejaculation disorders. The FDA did not start warning of these potential side effects until 2012—fifteen years after approving Propecia.
As a result, Propecia users have filed more than 1,400 lawsuits against drug maker Merck. The bulk of these cases have been consolidated into multi-district litigations (MDLs). The first cases are scheduled to go to trial in September 2017, but will likely be settled before then.
Merck’s History of Questionable Ethics
Merck & Co. is an American pharmaceutical giant founded by George Merck in 1917. Its 2015 revenue was $39.5 billion, making it one of the most profitable pharmaceutical companies in the world.
Its most notable products include the arthritis medication Vioxx, the river blindness medication Mectizan, the osteoporosis medication Fosamax, and of course Propecia and Proscar.
Like many Big Pharma corporations, Merck has a history of questionable ethics and business practices, especially pertaining to Vioxx:
- From 2002 to 2005, Merck’s Australian affiliate paid a Dutch publisher called Elsevier to put out a “medical journal” called the Australasian Journal of Bone and Joint Medicine. The journal presented itself as independent and peer-reviewed, and featured many articles that favored Merck medications.
- In 2007, Merck paid nearly $5 billion to settle several lawsuits related to Vioxx, which Merck pulled from the market in 2004 after the drug was shown to increase the risk of heart attacks and strokes.
- In 2008, Merck paid $650 million to settle U.S. Justice Department charges that it overcharged the Medicaid program for its drugs. This was one of the largest settlements of its kind in American history.
- In 2011, Merck paid $950 million settle yet another Justice Department charge, this one over its unlawful marketing of Vioxx.
- In 2016, Merck agreed to pay $830 million to settle a class action securities lawsuit regarding Vioxx.
Given its checkered history, it is not especially surprising that Merck now faces 1,240 lawsuits over Propecia—and will likely have to shell out hundreds of millions to settle these cases.
How Propecia Works
Propecia is an androgen blocker (or antiandrogen) that inhibits the production of dihydrotestosterone (DHT), reducing androgen in the scalp and prostate. This diminishes the size of the prostate and can decrease hair loss by as much as 30% after six months of use. (Propecia is only effective while being taken.)
The problem is that DHT activates the GABAA receptor, and diminished GABAA activity has been linked to sexual dysfunction (among other side effects). By curbing DHT production, Propecia increases the risk of impotence, erectile dysfunction, and other sexual side effects in men. (Propecia does not work for women.)
The FDA acknowledged the increased risks—but not until 2012, when Propecia had already been on the market for 15 years.
A Brief History of Propecia
The first iteration of finasteride was Proscar, a Merck drug used to treat an enlarged prostate, which the FDA approved in 1992. (Proscar actually contains five times as much finasteride as Propecia.)
Five years later, in 1997, the FDA approved finasteride for the treatment of male pattern baldness: Merck patented Propecia for this use. Though Merck’s original Propecia patent expired in 2006, it received another that lasted until 2013.
From 2003 to 2010, sales of Propecia soared from $239 million to $447 million.
In 2008—after widespread reports of sexual dysfunction in patients, and under pressure from Swedish medical authorities—Merck changed the label on the Swedish version of Propecia to warn against possibly permanent sexual side effects.
That same year, the Journal of Sexual Medicine published a study showing that as many as 38% of men taking Propecia could experience sexual side effects.
In 2009 and 2010, Merck changed Propecia labels in the UK and Italy to highlight potentially permanent sexual side effects—but not in the U.S.
In 2011, the FDA added a warning to Propecia that said it could increase the risk of prostate cancer.
It wasn’t until 2012—fifteen years after its approval, and four years after the Swedish label change—that the FDA finally warned American consumers about lasting sexual side effects caused by Propecia.
By this time, Propecia patients had coined a term encapsulating these side effects: Post Finasteride Syndrome. They also formed an advocacy group called the Post-Finasteride Syndrome Foundation.
Galvanized by the FDA label change, patients also began filing lawsuits against Merck for not warning consumers of the risks inherent in taking Propecia.
Over time, these lawsuits would number over 1,400.
Propecia and Sexual Dysfunction
Scientists have amassed a wealth of data demonstrating a strong link between Propecia and often-permanent sexual dysfunction. The studies cementing this link include the following:
- In 2008, the Journal of Sexual Medicine published a study showing that as many as 38% of men taking Propecia could experience sexual side effects.
- In 2011, the Journal of Sexual Medicine published a follow-up study that put the number at up to 23%. The study also noted that these side effects can linger for years after Propecia use has been discontinued.
- In April 2015, medical researchers at Northwestern University concluded, “Not one of the 34 published clinical trial reports provided adequate information about the severity, frequency or reversibility of [Propecia’s] sexual adverse effects.” (These findings appeared in JAMA Dermatology.)
- In September 2015, Men’s Journal warned against the risks associated with Propecia, and noted that its sexual side effects are likely underreported: “Men may have no idea that cognitive side effects would have anything to do with taking a hair-loss pill, particularly if those problems continue after they stop taking the drug. And many would be embarrassed to bring up sexual problems to a dermatologist or researcher, particularly a female.”
From the above (among other studies), it’s painfully clear that Propecia increases the risk of sexual dysfunction in men—even months and years after they’ve stopped using it. Hundreds of them have taken legal action.
Propecia Lawsuits and Settlements
Since 2011, more than 1,400 lawsuits have been filed against Merck over Propecia’s side effects. For logistical reasons, hundreds of these have been consolidated into multi-district litigations (MDLs). Originally scheduled to go to trial in Fall 2016, they have been pushed back to September 2017. (Please see our Propecia Lawsuit page for more information.)
Most likely, Merck will settle all of these lawsuits. Cases like these almost never go to trial, and these are even stronger given that Merck acknowledged as far back as 2008 (in its Swedish labels) that Propecia could cause permanent sexual side effects.
Settlements this large often total in the tens or hundreds of millions. Merck has already paid hundreds of millions over its marketing and sale of Vioxx, an arthritis medication that can cause heart attacks and strokes. According to Public Citizen, Merk paid $1.89 billion in lawsuit settlements from 2006-2015.
Plaintiffs often seek compensation for some combination of the following damages:
- Pain and suffering
- Medical bills
- Punitive damages
- Attorney fees
In the case of Propecia, the awards may be for pain and suffering and medical bills.