Does Picato gel increase the risk of squamous cell skin cancer? The complaint for this class action says it does and declares the medicine “defectively manufactured and unfit for [its] intended purpose[.]” It brings suit against LEO Pharma, Inc. and LEO Pharma AS for breach of the implied warranty of merchantability, claiming that Picato is “worthless.”
The class for this action is all persons in the US who bought Picato.
Plaintiff Brian Kamlade’s doctor diagnosed him with actinic keratosis, which the complaint describes as “a scaly, crusty lesion on the skin, caused by too much sunlight exposure.” His doctor prescribed Picato to treat it. Kamlade filled the prescription, paying $20 as a copayment, and used Picato on his skin. The complaint says, “After using the Picato gel as directed, he developed cancer in the area where the Picato was applied.”
The maker of Picato recommends it for treatment of actinic keratosis. However, in September 2019, upon reports of skin cancer incidents, the European Commission asked for a review of the medicine. The European Medicines Agency (EMA) suspended sales of Picato in January 2020, citing concerning results from earlier studies:
- A three-year study of 484 patients showed a 3.3% incidence of skin cancer with ingenol mebutate (the generic name of Picato) compared to 0.4% with a different drug.
- An eight-week, vehicle-controlled study with 1,262 patients showed an incidence showed a 1% incidence of skin tumors with ingenol mebutate compared to 0.1% in the other group.
- Four other clinical trials with 1,234 patients and ingenol dioxate, a related substance, showed an incidence of skin tumors in 7.7% of patients versus a control group with 2.9%.
The Pharmacovigilance Risk Assessment Committee (PRAC) carried out the review of Picato, and put out a report in April 2020 saying that Picato “may increase the risk of skin cancer” and finding that “the risks of the medicine outweigh its benefits.” The complaint also quotes the report as saying that “Picato’s effectiveness is no maintained over time and … that other treatment options are available for actinic keratosis.”
The EMA warned people who had used Picato to “look out for unusual skin changes or growths … and seek medical advice if any occur.”
In July 2020, Health Canada announced that, of twenty-nine case reports of skin cancer, twenty-six were “possibly linked” to Picato. It also reviewed twelve studies and found evidence of skin cancer with Picato use in six of them.
In October 2020, Health Canada asked LEO Pharma to recall Picato in Canada and told patients to discontinue treatment with the drug.
That same month, LEO Pharma said it was permanently discontinuing the drug.
Note that this class action asks for compensation for those who paid money for Picato. It does not ask for compensation for those who developed skin cancer.
Article Type: LawsuitTopic: medical
Most Recent Case Event
Picato Gel Alleged to Be “Worthless” Complaint
April 29, 2021
Does Picato gel increase the risk of squamous cell skin cancer? The complaint for this class action says it does and declares the medicine “defectively manufactured and unfit for [its] intended purpose[.]” It brings suit against LEO Pharma, Inc. and LEO Pharma AS for breach of the implied warranty of merchantability, claiming that Picato is “worthless.”
Picato Gel Alleged to Be “Worthless” ComplaintCase Event History
Picato Gel Alleged to Be “Worthless” Complaint
April 29, 2021
Does Picato gel increase the risk of squamous cell skin cancer? The complaint for this class action says it does and declares the medicine “defectively manufactured and unfit for [its] intended purpose[.]” It brings suit against LEO Pharma, Inc. and LEO Pharma AS for breach of the implied warranty of merchantability, claiming that Picato is “worthless.”
Picato Gel Alleged to Be “Worthless” Complaint