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Medical Legal Issues with Biologic Agents in the Treatment of Psoriasis

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Abstract

Although biologic drugs have changed the face of psoriasis treatment, affording greater efficacy and enhancing quality of life, safety issues have been reported and the warning labels have expanded. A variety of issues are now linked to biologic associated tumor necrosis factor-alpha (TNF-α) blocker use. Litigation has occurred with the use of a variety of biologics. The published risks of these agents include the development of lupus and autoimmune-like syndromes, squamous cell cancer (SCC), histoplasmosis, and coccidioidomycosis. This chapter focuses on litigation related to the use of biologics in dermatology, approaches to reducing physician liability, and hypothetical lawsuits against a dermatologist using biologics.

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References

  1. Scheinfeld N. Biologics and malpractice. Dermatologist. 2014;22:2.

    Google Scholar 

  2. Papp K, Gottlieb AB, Naldi L, et al. Safety surveillance for ustekinumamb and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Drugs Dermatol. 2015;14:706–14.

    CAS  PubMed  Google Scholar 

  3. American Academy of Dermatology. Psoriasis: TNF inhibitors general recommendations. 2016. https://www.aad.org/pratice-tools/quality-care/clinical-guidelines/psoriais/biologigs/tnf-inhibiyots-recommendations. Accessed June 14, 2016.

  4. Dommasch E, Gelfand JM. Is there truly a risk of lymphoma from biologic therapies? Dermatol Ther. 2009;22:418–30.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Kimball AB, Rothman KJ, Kricorian G, et al. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015;72:115–22.

    Article  PubMed  Google Scholar 

  6. Menter A, Thaci D, Papp KA, et al. Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis. J Am Acad Dermatol. 2015;73:410–9. E6.

    Article  CAS  PubMed  Google Scholar 

  7. Larson v Abbott. Civil Action No. ELH-13-00554, United States District Court for the District of Maryland. 2016. http://www.mdd.uscourts.gov/Opinions/Opinions/Larson-AbbottMemo.pdf, Accessed November 17, 2016.

  8. DiBartolo v Abbott Laboratories, 914 F. Supp. 2d 601 (Southern District NY). 2012.

    Google Scholar 

  9. Humira lawsuit filed by a man with fungal infection. AboutLawsuits.com website. 2014. http://www.aboutlawuits.com/humira-fungal-infection-law suit-18807/. Accessed January 28, 2014.

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Correspondence to David J. Goldberg MD, JD .

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Goldberg, D.J., Gibofsky, A. (2018). Medical Legal Issues with Biologic Agents in the Treatment of Psoriasis. In: Yamauchi, P. (eds) Biologic and Systemic Agents in Dermatology. Springer, Cham. https://doi.org/10.1007/978-3-319-66884-0_6

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  • DOI: https://doi.org/10.1007/978-3-319-66884-0_6

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-66883-3

  • Online ISBN: 978-3-319-66884-0

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