MDedge Dermatology

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Interruption of upadacitinib treatment caused rapid loss of skin clearance response and upadacitinib retreatment led to rapid recovery or improvement in the response in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A dose of 30 mg upadacitinib vs placebo led to a 72.9% least-squares mean percentage improvement in the Eczema Area and Severity Index (EASI) score by week 16, which decreased to 24.6% within 4 weeks of upadacitinib withdrawal; however, an 8-week rescue therapy (30 mg upadacitinib) improved the mean percentage EASI score (pre- vs post-therapy: 2.8% vs 84.7%).

Study details: This post hoc analysis of a phase 2b study included 167 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (7.5, 15, or 30 mg) or placebo; at week 16, each group was reassigned to receive upadacitinib (same dose) or placebo, with rescue therapy (30 mg upadacitinib) initiated in those with < 50% EASI response at week 20.

Disclosures: This study was sponsored by AbbVie, Inc. Six authors declared being employees of or holding stock or stock options in AbbVie. Several authors reported ties with AbbVie and others.

Source: Guttman-Yassky E et al. Upadacitinib treatment withdrawal and retreatment in patients with moderate-to-severe atopic dermatitis: Results from a phase 2b, randomized, controlled trial. J Eur Acad Dermatol Venereol. 2023 (Aug 1). doi: 10.1111/jdv.19391

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

A version of this article first appeared on Medscape.com.

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

A version of this article first appeared on Medscape.com.

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

A version of this article first appeared on Medscape.com.

If you’re looking to grow hair, you might just have a solution in your kitchen cabinet – if TikTok and some dermatologists are correct.

A small study published in 2015 suggested that rosemary oil may help regrow hair in people with androgenetic alopecia. The herb might also protect hair from the sun, pollution, and other environmental elements, according to an article in Insider.

The study published in Skinmed found that rosemary oil was similar to the effectiveness of minoxidil for regrowing hair in men with androgenetic alopecia. The scalp was also less itchy after 3-6 months of use.

The study included only men.

Still, dermatologist Shilpi Khetarpal, MD, told the Cleveland Clinic that it seems to work.

“The study really prompted people to look at rosemary oil for hair growth,” she said. “It became much more common in over-the-counter products after that, too.”

The Cleveland Clinic also reports that rosemary oil might help against dandruff and premature graying.

Dr. Khetarpal suggested massaging rosemary oil into the scalp, letting it soak overnight, and then washing it out. This should be done two or three times a week. 

She also noted that only a few drops of rosemary oil are needed, and that the focus should be on the scalp rather than the hair, which rosemary oil makes look greasy.

It may take 6 months for “meaningful improvement,” Dr. Khetarpal said.

Meanwhile, TikTok users love hyping the oil’s hair care qualities. On the social media platform, videos with the hashtag #rosemaryoil have been viewed more than 2 billion times.
 

A version of this article appeared on WebMD.com.

If you’re looking to grow hair, you might just have a solution in your kitchen cabinet – if TikTok and some dermatologists are correct.

A small study published in 2015 suggested that rosemary oil may help regrow hair in people with androgenetic alopecia. The herb might also protect hair from the sun, pollution, and other environmental elements, according to an article in Insider.

The study published in Skinmed found that rosemary oil was similar to the effectiveness of minoxidil for regrowing hair in men with androgenetic alopecia. The scalp was also less itchy after 3-6 months of use.

The study included only men.

Still, dermatologist Shilpi Khetarpal, MD, told the Cleveland Clinic that it seems to work.

“The study really prompted people to look at rosemary oil for hair growth,” she said. “It became much more common in over-the-counter products after that, too.”

The Cleveland Clinic also reports that rosemary oil might help against dandruff and premature graying.

Dr. Khetarpal suggested massaging rosemary oil into the scalp, letting it soak overnight, and then washing it out. This should be done two or three times a week. 

She also noted that only a few drops of rosemary oil are needed, and that the focus should be on the scalp rather than the hair, which rosemary oil makes look greasy.

It may take 6 months for “meaningful improvement,” Dr. Khetarpal said.

Meanwhile, TikTok users love hyping the oil’s hair care qualities. On the social media platform, videos with the hashtag #rosemaryoil have been viewed more than 2 billion times.
 

A version of this article appeared on WebMD.com.

If you’re looking to grow hair, you might just have a solution in your kitchen cabinet – if TikTok and some dermatologists are correct.

A small study published in 2015 suggested that rosemary oil may help regrow hair in people with androgenetic alopecia. The herb might also protect hair from the sun, pollution, and other environmental elements, according to an article in Insider.

The study published in Skinmed found that rosemary oil was similar to the effectiveness of minoxidil for regrowing hair in men with androgenetic alopecia. The scalp was also less itchy after 3-6 months of use.

The study included only men.

Still, dermatologist Shilpi Khetarpal, MD, told the Cleveland Clinic that it seems to work.

“The study really prompted people to look at rosemary oil for hair growth,” she said. “It became much more common in over-the-counter products after that, too.”

The Cleveland Clinic also reports that rosemary oil might help against dandruff and premature graying.

Dr. Khetarpal suggested massaging rosemary oil into the scalp, letting it soak overnight, and then washing it out. This should be done two or three times a week. 

She also noted that only a few drops of rosemary oil are needed, and that the focus should be on the scalp rather than the hair, which rosemary oil makes look greasy.

It may take 6 months for “meaningful improvement,” Dr. Khetarpal said.

Meanwhile, TikTok users love hyping the oil’s hair care qualities. On the social media platform, videos with the hashtag #rosemaryoil have been viewed more than 2 billion times.
 

A version of this article appeared on WebMD.com.