In this series: Overview • Part 1 • Part 2 • Part 3
All but one document below are filings from lawsuits alleging persistent adverse effects of Propecia and Proscar in the United States and Canada, dating from 2011 to 2021.
- Rosello & Herrman v. Merck in U.S. District Court in New Jersey
- Dawson v. Merck, consolidated into a multi-district litigation (MDL) in U.S. District Court, Eastern District of New York
- Miller v. Merck Frosst Canada et al. in a court in British Columbia, Canada
- Baratto v. Merck Canada Inc. and Merck Frosst Canada & Cie in a court in Quebec, Canada
In quoted excerpts below, emphasis has been added in bold.
See also: History of lawsuits
Lawsuits in the United States
Rosello & Herrman v. Merck in U.S. District Court, New Jersey: Complaint
Feb 2, 2011 • View document (13 pages)
Two men residing in Texas and Nevada sued Merck over persistent sexual dysfunction associated with use of Propecia. The Complaint points out that, while reports of persistent erectile dysfunction were added to the drug label in Sweden in 2009, the Propecia.com website did not mention this adverse effect as of the date of this filing. The information available to patients in the U.S. is therefore:
deceptive and misleading in that it fails to advise potential users of the drug that numerous men have reported suffering persistent sexual side effects even after discontinuing use… Plaintiffs would not have taken finasteride had they or their physicians been adequately warned of the risks.
The complaint makes three counts: Negligence and Failure to Warn; Strict Products Liability; and Breach of Warranty. The Defendants demand a judgment against Merck “in an amount in excess of $100,000…”
Merck email correspondence regarding identification of cases of persistent sexual dysfunction associated with Propecia
Apr 6, 2011 • View document (2 pages)
In this internal Merck email, Christine Alberts forwards to Cythia Silber, a Merck Medical Director, the search criteria used to identify cases of persistent sexual dysfunction in Merck’s Worldwide Adverse Experience System. An attachment describes the search criteria:
To identify cases that may represent persistent sexual dysfunction the MAH [Marketing Authorization Holder, i.e. Merck] reviewed the reports with an outcome of not recovered in whom finasteride therapy was discontinued. A total of 446 spontaneous reports meeting this criteria were identified […].
Propecia Multi-District Litigation (MDL) in New York: Transcript of deposition of Elizabeth Round, MD (excerpt)
Dec 17, 2015 • View document (52 pages)
Dawson v. Merck, filed in 2011, was consolidated into multi-district litigation (MDL) in U.S. District Court, Eastern District of New York in 2012. The plaintiffs alleged Merck was liable for persistent sexual dysfunction associated with their use of Propecia or Proscar. (Merck reported approximately 1,400 plaintiffs in Propecia litigation at the end of 2015, encompassing the MDL and other lawsuits.)
As part of the MDL, Dr. Elizabeth Round of Merck is deposed by plaintiffs’ attorney Becker. Becker refers to Dr. Round as a “25-year employee of Merck” (p. 18). Becker asks Dr. Round about an article by Abdulmaged Traish describing persistent sexual dysfunction and depression associated with previous use of finasteride (pp. 2–13).
Dr. Round acknowledges a man with sexual dysfunction 66 days after discontinuing Propecia (p. 14). Dr. Round acknowledges that Sweden had required an update to the Propecia label based on postmarketing reports of persistent sexual dysfunction (p. 19). In response to a question about persistent sexual adverse events (AEs) in years 3–5 of Propecia clinical trials, Dr. Round acknowledges: “there are reports of persistent sexual adverse events in the Merck database” (pp. 20–21). Dr. Round acknowledges that, with awareness of Dr. Traish’s 2010 article on persistent sexual dysfunction associated with finasteride, Merck did not take action regarding the Propecia label in the U.S. (p. 24, line 5).
Attorney Becker pursues a line of questioning on whether Merck should have provided more information about the length of time to resolution of persistent sexual AEs (pp. 30–40). Becker asks Dr. Round about an article by Michael Irwig, ‘Persistent Sexual
Side Effects of Finasteride for Male Pattern Hair Loss’ (p. 24). Dr. Round declines to confirm that the article describes men with persistent sexual dysfunction: “I don’t have a definition for persistent” (p. 30, lines 13–14). Dr. Round points out limitations of the study:
The persistence of sexual AEs has been added to the label based on postmarketing. We’ve also established that postmarketing data is limited. And this author himself cites the limitations of this study; the post hoc approach, selection bias, record bias, no serum hormone level. [p. 32]
Dr. Round acknowledges that Merck was aware of sexual AEs where men had a status of “not recovered” (p. 42):
Q: To identify cases that may represent persistent sexual dysfunction, the MAH [Marketing Authorization Holder, Merck] reviewed the reports with an outcome of not recovered in whom finasteride therapy was discontinued. Do you see that there?
Q: And it found a total of 446 reports, right?
Becker pursues questions about the lack of a term for persistence of sexual dysfunction in Merck’s AE database. Becker presses Dr. Round as to whether Merck sought to add a term for persistent sexual dysfunction to their database or search narrative reports already in the database (pp. 43–47).
Becker mentions an email dated 2000 referring to persistent ongoing sexual dysfunction, but the next pages are not included in this PDF (p. 49).
In the final pages of this excerpt, Dr. Round acknowledges that patients could not make an informed choice regarding the risk of persistent sexual dysfunction from Propecia (pp. 51–52; attorney objections omitted here):
Q [BY MR. BECKER]. How does a patient make an informed choice if they don’t know the risk is present?
[THE WITNESS]: They can’t.
Q. Exactly. And so prior to 2012 when the FDA approved the label, the only person or people that could make that assessment was Merck, right?
THE WITNESS: Based on the label in the U.S., the physician did not have that information.
Q. Right. So the only people that had that information at their disposal were, in fact, Merck, right?
THE WITNESS: It was in the EU label.
Q. Right. But you testified earlier, you have no idea if you gave this document to the FDA, right?
THE WITNESS: I did.
Q. And so if the FDA didn’t have this data, there would be no way they could evaluate it, right?
Propecia MDL: Transcript of deposition of Cynthia Grossel Silber, MD (excerpt)
Apr 19, 2016 • View document (25 pages)
According to a LinkedIn profile, Dr. Silber was a Medical Director, Clinical Risk Management from 2007–2021. This excerpt from Dr. Silber’s deposition focuses on her analysis of safety signals based on pharmacovigilance data, consisting of adverse event reports, associated with finasteride. Plaintiffs’ attorney Becker asks whether Dr. Silber had the appropriate background to analyze safety signals from adverse event data. Becker goes on to ask about how safety signals of Propecia were analyzed within Merck. The focus is on whether it is possible to detect a signal of persistent sexual dysfunction from adverse event data, and whether Merck had detected such a signal. From pp. 16–18:
Q. So from whatever the date was, whether it was 2006 or ‘7 or ‘8 or whenever you joined the Propecia team, is it your testimony you never engaged in signal detection related to Propecia and persistent ongoing sexual dysfunction?
A. I engaged in signal evaluation. The signal had been identified by the time I joined the program. It had already been reviewed.
Q. […] Are you saying that there was a signal that was identified between Propecia and persistent sexual dysfunction prior to your joining the team?
A. Prior to my joining the team, there was investigation of that product-event combination, yes.
Q. And what was the outcome?
A. The outcome when I joined the team was that persistent erectile dysfunction was not causally associated with Propecia.
Q. So there was no signal by the time you — when you joined the team, the view of Merck was that there was no signal establishing an association between Propecia and persistent ongoing sexual dysfunction following discontinuation of use?
A. I don’t think I would say there was — there had been a signal and we were following it on an ongoing basis.
In the remaining pages of this excerpt, Becker pursues questions about the delay between when Merck may have identified a signal of persistent erectile dysfunction associated with Propecia, and when the U.S. label was updated to indicate this adverse event (which occurred in 2012).
Propecia MDL: Transcript of deposition of Charlotte Merritt (excerpt)
May 19, 2016 • View document (6 pages)
According to a LinkedIn profile, Charlotte Merritt was in Regulatory Affairs and product labeling roles at Merck from 1990 to 2013. In this excerpt, plaintiffs’ attorney Fisher asks Merritt about a 2002 change to the U.S. label in which “all” was dropped from the phrase “Resolution occurred in all men who discontinued therapy” (as described in Part 1). Merritt acknowledges cases from clinical trials of men who discontinued the trial and did not have resolution of an adverse event (p. 6):
Q. And the standby statement includes […] the following statement: “In the Phase 3 clinical trials for Propecia, resolution of erectile dysfunction occurred in men who discontinued therapy because of this side effect.” Do you see that?
Q. And we talked […] about the fact that between the 2001 and 2002 label — labels the word “all” was removed before the word “men” there, right?
Q. Because there were cases in the clinical trials of men who discontinued therapy and did not have resolution of the adverse event, right?
A. Yes, that’s been established.
Propecia MDL: Transcript of deposition of Paul Howes (excerpt)
Jun 7, 2016 • View document (41 pages)
According to a LinkedIn profile, Howes was a Vice President of Sales & Marketing at Merck from 1998–2001. In pages 1–25, plaintiffs’ attorney Becker pursues a line of questioning about Merck’s sales and marketing strategy in the 1990s, in the context of expiring patents in its portfolio. From p. 26, Becker refers to an internal marketing memo which indicated that Merck was aware sexual side effects could adversely affect the drug’s appeal in the market. From p. 33, the attorney refers to an internal marketing study which quantified the potential impact of sexual side effects on sales. On p. 41, Howes confirms the attorney’s statement about this potential impact:
Q. So the walkaway from this was that we understand we have a problem with sexual side effects, and we, as a company, have to figure out how to address that.
Propecia MDL: Transcript of deposition of Keith Kaufman, MD (excerpt)
Jul 12, 2016 • View document (13 pages)
Plaintiffs’ attorney Becker deposes Dr. Kaufman, the head of clinical development for Propecia. On pp. 5–8, Becker pursues questions about a participant in years 3–5 of the Phase III clinical trials, in whom sexual adverse events were not resolved 66 days after discontinuing the medication, and in whom these AEs were still not resolved six months after discontinuation.
Q. So six months following discontinuation, this patient still was suffering from the adverse event, correct?
A. The patient was still reporting the adverse event.
On pp. 9–10, Becker seeks Dr. Kaufman’s confirmation that Merck did not know whether seven patients reporting sexual AEs at the end of the study had subsequent resolution of those AEs (witness attorney objections are omitted):
Q. And you have no idea how long those adverse events continued for, correct?
THE WITNESS: If we don’t have the data, then we don’t know.
Q. Okay. But for the next 16 men, you do appear to have the data, correct?
A. Right. But what that means is that the patients achieved resolution either on or off therapy while they were still participating in the trial. Once the trial is over, we usually lose contact with the patient.
Propecia MDL: Plaintiff’s Executive Committee Motion for Approval of Settlement Plan
Apr 10, 2018 • View document (13 pages)
As background, Merck’s 2019 10-K filing described the settlement of Multi-District Litigation (MDL) in New York and Coordinated Proceedings in New Jersey:
As previously disclosed, on April 9, 2018, Merck and the Plaintiffs’ Executive Committee in the Propecia MDL and the Plaintiffs’ Liaison Counsel in the NJ Coordinated Proceedings entered into an agreement to resolve the above mentioned Propecia/Proscar lawsuits for an aggregate amount of $4.3 million. The settlement was subject to certain contingencies, including 95% plaintiff participation and a per plaintiff clawback if the participation rate was less than 100%. The contingencies were satisfied and the settlement agreement was finalized. After the settlement, fewer than 25 cases remain pending in the United States.
The Company intends to defend against any remaining unsettled lawsuits.
This motion includes an Allocation Plan which “sets forth various categories and levels of compensation based upon an individual Claimant’s proof of use of Propecia and evidence of injury.” (p. 6) The Allocation Plan comprises five categories (pp. 8–9):
- Category One: “men whose primary proof of erectile dysfunction is based upon evidence the man was prescribed a PDE5-inhibitor (e.g., Viagra® or Cialis®) during or after discontinuation of Propecia.”
- Category Two: “men whose primary proof of erectile dysfunction stems from a man who saw his Primary Care Provider (“PCP”) who, in turn, made a diagnosis of erectile dysfunction.”
- Category Three: “men whose primary proof of erectile dysfunction stems from a diagnosis by a specialist (e.g., urologist or endocrinologist) who diagnosed the man with erectile dysfunction.”
- Category Four: “men who saw a specialist who rendered a causation diagnosis. Specifically, this includes men where the specialist attributed the man’s erectile dysfunction to his Propecia use (e.g., erectile dysfunction secondary to Propecia/finasteride use).”
- Category Five: “men whose claims do not fall into any of the previous categories. These include claims […] that Propecia caused prostate cancer, breast cancer, genital disfigurement, and gynecomastia or whose proof of harm is not sufficient to fall within Categories One through Four […]”
According to a DrugWatch article, the minimum awards were: Category 1: $1,000; Category 2: $2,000; Category 3: $3,500; Category 4: $5,000; and Category 5: variable, from $500–$5,000.
Propecia MDL: Order on Motion to Unseal by Magistrate Judge Kuo
Jan 24, 2021 • View document (22 pages)
In 2018, while motions were pending regarding documents which were either redacted or filed under seal, a settlement agreement was reached (see above) and the case was dismissed (p. 2). In 2019, Reuters America sought to unseal certain documents. The defendant, Merck, opposed the motion.
Judge Peggy Kuo states (p. 15): “[T]he Court concludes that Defendants’ arguments in favor of continued sealing are so weak that they would not overcome even a low presumption of access under the common law.” On pp. 15–22, Judge Kuo discusses implications of unsealing specific documents.
On p. 22, Judge Kuo grants Reuters’ motion to unseal all but two documents. Dockets 115-29 and 115-30 shall remain under seal.
Lawsuits in Canada
Miller v. Merck Frosst Canada et al. in the Supreme Court of British Columbia, Canada: Judgment on defendant’s request for plaintiffs’ medical records
Dec 21, 2011 • View document (19 pages)
Miller states that he suffered permanent sexual dysfunction as a result of taking Proscar (finasteride 5 mg). He wishes to be a representative plaintiff for a class action against Merck brought by men who suffered permanent sexual dysfunction after taking Proscar or Propecia (p. 3). At this time the class had not been certified. Justice R. Punnett weighs the defendant Merck’s request that certain plaintiffs produce their medical and pharmaceutical records. The judge declines the request, explaining that Merck is
seeking evidentiary proof of the facts alleged as they relate to one or more individuals. This constitutes a clear intrusion into the merits of the [plaintiff’s] claim. Therefore, I am not satisfied that the defendants have shown that the circumstances of this case are so exceptional that the requested medical records are required for certification. [p. 17]
Baratto v. Merck Canada Inc. and Merck Frosst Canada & Cie, a class action in Quebec Superior Court, Canada
Dec 4, 2020 • View document (16 pages, in French)
Background: According to a 2018 article in the Globe and Mail, plaintiff Baratto took Proscar for one month in 2008, but was still suffering sexual and psychological adverse effects when the lawsuit was filed in 2013. A lower court reportedly declined to certify the class in 2016, a decision later overturned by Quebec Superior Court.
This legal document was filed in Quebec Superior Court in December 2020 by plaintiffs’ counsel. It is a demand for the court to institute proceedings including “recovery of the Class Members’ claims for punitive damages […] with costs, including the costs of advice and experts […]” (pp. 15–16).
A page on the website of plaintiffs’ counsel Trudel Johnston notes: “Among other things, the plaintiff will file its expert reports by May 31, 2021, and the defendants must file their written defence by July 30, 2021. This schedule will allow the case to move forward and be ready to set trial date by the end of 2021.”
In this series: Overview • Part 1 • Part 2 • Part 3
See also: History of lawsuits