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Thursday, March 28, 2024

Merck faces products liability claim over failure to properly warn of Propecia side effects

Michael b. leh

An Illinois man has filed a products liability complaint against drugmaker Merck & Co.

over allegations that the defendant’s hair treatment prescription medication Propecia can lead men to develop side effects such as sexual dysfunction.

Attorneys Michael B. Leh and Pamela A. Lee, of the Philadelphia-based Locks Law Firm, filed the lawsuit Feb. 5 at the U.S. District Court for the Eastern District of Pennsylvania on behalf of Steven Oberc, who resides in Munster, Ill.

The defendants named in the complaint are New Jersey-based Merck & Co. and Merck Sharp & Dohme Corp.

The lawsuit claims that the defendants knew or should have known that Propecia, which is used to treat male baldness, when taken as prescribed and intended, causes and contributes to an increased risk of serious and dangerous side effects such as cognitive impairment, development of depression, and various forms of sexual dysfunction such as erectile dysfunction, reduced or diminished libido, reduced sexual sensation and infertility.

Propecia, or finasteride, was initially developed to treat patients with symptoms of benign prostatic hyperplasia, or BPH, and then later approved for the treatment of androgenic alopecia, more commonly known as male pattern hair loss, the suit states.

The FDA approved Propecia as a baldness treatment in 1997.

The complaint states that the defendants, in their product labeling for Propecia, represented that a very small number of users may experience side effects including sexual dysfunction and depression.

But while the defendants soon went on to change the warning label on Propecia in other countries to reflect the risks of such side effects since the dangers became more widely known, the lawsuit claims that the drug manufacturers have yet to properly update the label in the United States as required by the Food and Drug Administration.

This past spring, the suit claims, the FDA announced that the label was in the process of being changed but as of the date of the filing of this lawsuit, the plaintiff’s attorneys wrote, the revised wording has not yet been made public.

“Each defendant was under a continuing duty to disclose the true character, quality, and nature of its drug that Plaintiff Steven Oberc ingested, but instead concealed them,” the complaint reads. “As a result, each defendant is estopped from relying on any statute of limitations defense.”

The suit claims that the Propecia the plaintiff used was “unreasonably dangerous” when it entered the stream of commerce and was received by Oberc, and that at no time did the plaintiff have reason to believe that the medication was in a condition that was not suitable for its proper and intended use among patients.

“Plaintiff was not able to discover, nor could he have discovered through the exercise of reasonable care, the defective nature of Propecia,” the complaint states. “Further, in no way could Plaintiff have known that Defendants had designed, developed, and manufactured Propecia in such a way as to increase the risk of harm or injury to the recipients of Propecia.”

The lawsuit contains counts of strict liability, negligence, breach of implied and express warranties, fraud, negligent infliction of emotional distress, and violations of unfair and deceptive trade practices acts.

Oberc seeks unspecified compensatory and punitive damages, in addition to attorney’s fees, pre-and-post-judgment interest and other court relief.

 

The federal case number is 2:13-cv-00659-MSG.

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