See also: litigation document excerpts in The Merck files, part 3: Propecia lawsuits.
Propecia (Finasteride) Product Liability Litigation
2011 Feb 2: A complaint, Rosello & Herman v. Merck & Co., Ltd. et al., is filed in U.S. District Court for the District of New Jersey. The complaint makes three counts: Negligence and Failure to Warn; Strict Products Liability; and Breach of Warranty.
2011 Aug 18: A complaint, Dawson v. Merck, is filed in the Western District of Washington (1:12-cv-01876).
2012 Apr 16: 9 cases including the above are consolidated into a multi-district litigation (MDL) in U.S. District Court, Eastern District of New York (MDL No. 2331).
2015–2016: Plaintiffs’ counsel deposes Merck employees involved in development, marketing and monitoring of Propecia (excerpts here).
Settlement plan approved
2018 Apr 10: A Settlement Plan is approved by more than 95% of Plaintiffs. Merck later stated in an SEC filing:
As previously disclosed, on April 9, 2018, Merck and the Plaintiffs’ Executive Committee […] 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.10-K filing, 27 Feb 2019
Certain terms of this settlement are described in The Merck files, part 3.
Unsealing of certain litigation documents
2019 Sep 12: Reuters America, which had been covering the Propecia litigation, submitted a motion to unseal certain documents from the litigation.
2021 Jan 24: Magistrate Judge Peggy Kuo ordered certain documents to be unsealed.
Post-Finasteride Syndrome Foundation v. Food and Drug Administration
In September 2021, the Post-Finasteride Syndrome Foundation sued the FDA over its lack of response to a Citizen Petition filed in 2017. The PFS Foundation was represented by Public Citizen, which posted a press release with a link to the complaint. The lawsuit was filed in U.S. District Court, District of Columbia.
On June 8, 2022, FDA responded to the Citizen Petition. FDA’s letter required Organon, the current marketer of Propecia, to make certain changes to Prescribing Information and Patient Information. See more details in the timeline (2022). On June 9, the Post-Finasteride Syndrome Foundation withdrew its lawsuit.
Miller v. Merck Frosst Canada Ltd. et al.
Full name of case: Michael Miller v. Merck Frosst Canada & Co., Merck & Co., Inc., Merck Sharpe & Dohme Corp, filed in British Columbia, Canada.
2011 Jan (2011 BCSC 1759): Michael Miller applies to have the action certified as a class.
2011 Dec 21: Justice R. Punnett declines Defendant application for representative plaintiff and others to produce medical and pharmaceutical records.
2013 (2013 BCSC 544), Justice Punnett certifies a class with Mr. Miller as representative plaintiff.
2015 (2015 BCCA 353): The Court of Appeal for British Columbia dismisses Merck’s appeal of the class action certification.
No further information on this case has been discovered.
Baratto v. Merck Canada Inc. and Merck Frosst Canada & Cie
This case was filed in Quebec Superior Court. 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. Further details on this suit are in The Merck Files, part 3.