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.
Unfortunately, Propecia also causes serious and lasting 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.
Due to the company’s lack of adequate warnings, Propecia users have filed more than 1,400 lawsuits against Merck. The bulk of these cases have been consolidated into multi-district litigations (MDLs) and are still pending as of May 2016.
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.)
Propecia increases the risk of impotence, erectile dysfunction, and other sexual side effects in men.
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. By this time, hundreds if not thousands of men had experienced sexual side effects from a drug that was supposed to make them feel more confident and virile, not less.
Just as disturbing, a study at Northwestern University found, “Not one of the 34 published clinical trial reports provided adequate information about the severity, frequency or reversibility of [Propecia’s] sexual adverse effects.”
This is just the tip of the iceberg in terms of damning data.
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. As a result, hundreds of patients 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.
Merck acknowledged as far back as 2008 that Propecia could cause permanent sexual side effects.
Most likely, Merck will settle all of these lawsuits before they go to court. Cases like these almost never go to trial, and these particular suits 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.
That amount is not as much of an outlier as one would expect. Many drug companies paid over a billion dollars in settlements over that span, and some paid even more than Merck:
- GlaxoSmithKline: $7.63 billion
- Pfizer: $3.46 billion
- Johnson & Johnson: $2.82 billion
- Abbott: $1.82 billion
- Eli Lilly: $1.71 billion
- Teva: $1.47 billion
- Novartis: $1.23 billion
Though it’s impossible to know how much Merck will offer to settle these 1,240 Propecia lawsuits, if history is any indication, it will be a sizable sum.
LAWSUIT ELIGIBILITY AND COMPENSATION
Propecia plaintiffs 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. A reduced libido (not to mention impotence and erectile dysfunction) can put a serious strain on a relationship, and even contribute to its dissolution. And many patients who experience impotence take Viagra, which means they need compensation for medical bills as well.