Leo Pharma agrees to pay $437K to settle lawsuit over skin cancer risk from Picato

By Karunjit Singh ·

Law360 Canada (February 5, 2025, 4:11 PM EST) -- Toronto-based Leo Pharma has agreed to pay $437,678 to settle a class action lawsuit alleging that its actinic keratosis treatment, Picato, increased patients’ risk of developing squamous cell carcinoma, a type of skin cancer.

Picato was previously approved for treating actinic keratosis but has been linked to an increased risk of non-melanoma skin cancers. Findings by regulators such as Health Canada that Picato may be associated with an increased risk of cancer has led to product recalls.

The plaintiff, Gerald Stewart, had commenced the class action against Leo Pharma. alleging, among other things, that it had been negligent in manufacturing and marketing Picato when it knew or ought to have known that it had potential risks that outweighed its potential benefits.

The lawsuit also alleged that Leo Pharma failed to implement a product recall of Picato once it knew the risks.

The proposed class action sought general, special and punitive damages on behalf of all persons living in Canada who were prescribed and used Picato.

The B.C. Supreme Court has certified the class action for the purposes of implementing the proposed settlement agreement, according to a release by class counsel Rice Harbut Elliott LLP. The class consists of all persons who purchased and/or used Picato in Canada between Jan. 1, 2013, and the present.

The release noted that the settlement did not constitute an admission of liability, wrongdoing, or fault by Leo Pharma.

Under the proposed agreement, the remaining settlement funds after deductions for class counsel fees, disbursements, administration expenses and an honorarium will be distributed equally between the Canadian Skin Cancer Foundation's GoSafe Sun safety program and the Law Foundation of British Columbia.

The settlement is subject to approval from the court. Any class members who wish to opt out of the settlement must notify class counsel by March 28, 2025.

Leo Pharma did not immediately respond to a request for comment.

If you have any information, story ideas, or news tips for Law360 Canada on business-related law and litigation, including class actions, please contact Karunjit Singh at karunjit.singh@lexisnexis.ca or 905-415-5859.