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    Medical malpractice: Doctor sued for negligence after patient dies due to efalizumab prescription


    David Goldberg
    Dr. Skin has a large dermatology practice with an emphasis on psoriasis. Many of his fellow dermatologists refer their most difficult patients to him. In fact, Dr. Skin prides himself on his ability to manage these most difficult psoriatic patients.

    Since 2004, he has been a strong advocate of using efalizumab for treatment-resistant psoriasis. Many patients have been successfully treated. As expected, many patients have had some side effects; all have been manageable.

    Dr. Skin has seen dose-related headaches, fever, nausea and vomiting in some patients during their initial dosing. In addition, because of the rare reports of drug-related thrombocytopenia and/or hemolytic anemia, Dr. Skin has all efalizumab patients checking their liver function tests, platelets and complete blood counts every three months. All his patients did well with efalizumab until one of his patients, a married, highly successful businessman with three children who had virtually no prior difficulty with this recombinant monoclonal antibody treatment during three years of treatment, died in 2007 of JC virus-induced progressive multifocal leukoencephalopathy (PML).

    Although Dr. Skin is saddened by his patient's death, he assumes this was a rare tragedy that was unrelated to the patient's treatment.

    Negligence

    Soon thereafter, the deceased patient's family brings a lawsuit against Dr. Skin alleging he was negligent in prescribing efalizumab, and that the efalizumab caused the death of their family member. Worse than that, the family files a wrongful death lawsuit against Dr. Skin.

    Dr. Skin, of course, is beyond horrified and hires an attorney to defend him. After extensive discussions, the attorney and defendant physician seek to have the case thrown out of court.

    During the mandatory lawsuit-required discovery period, it is determined that at least one other patient given efalizumab has also died from PML. Based on this information, the judge in the case denies Dr. Skin's motion for summary judgment.

    As time goes on, it becomes clear that there are two other known cases of potentially efalizumab-related PML, and perhaps there are others. The manufacturer of the drug decides to implement a phased voluntary withdrawal of the drug from the market.

    With this information, plaintiff's attorney seeks to settle the case with Dr. Skin for $6 million. Dr. Skin becomes very depressed. His career, practice, reputation and everything he holds dear are at risk, simply because he tried to be a good doctor. Should he try to defend himself? Will he lose the case at trial?

    A medical malpractice case, based on negligence, can only be won by the plaintiff's attorney if four elements can be proved in a court of law: duty, breach of duty, causation and damages. A physician is required to perform his duty, as would be any reasonable physician. If he does not do so, he has breached that duty. Then, if there is a nexus between the breach of that duty and damages, the plaintiff may win her lawsuit.

    Clearly, the death of Dr. Skin's patient has the requisite element of damages. Those damages are measured by the economic value that would be present if the deceased were still alive. However, did Dr. Skin perform in accordance with a reasonable duty, and if not, did the breach of that duty lead to his patient's death?

    Outcome

    If Dr. Skin had prescribed efalizumab and not routinely checked his patient's platelet count, the death of his patient from thrombocytopenia could be considered related to Dr. Skin's not checking the platelet count. Similarly, if with today's current knowledge of the potential association between efalizumab and PML, Dr. Skin had not discussed the voluntary withdrawal of the drug and the need to consider alternative treatments, this, too, would be considered a breach of the reasonable duty.

    However, at the time Dr. Skin's patient died from PML, a reasonable physician could not have known of the association of PML with efalizumab. Therefore, Dr. Skin did not breach his duty in prescribing the drug to his patient, and he is not likely to lose the lawsuit.

    David Goldberg, M.D., J.D., is director of SkinLaser & Surgery Specialists of New York and New Jersey, director of Mohs surgery and laser research, Mount Sinai School of Medicine, and adjunct professor of law, Fordham Law School.

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    David J. Goldberg, M.D., J.D.
    Dr. Goldberg is Director of Skin Laser & Surgery Specialists of New York and New Jersey, Director of Mohs Surgery and laser research, ...

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