Negligent Administration of Excessive Steroids For Lupus - Steroid-Induced Myopathy

WRSMH attorney Philip Russotti recently obtained a verdict in a case that was venued and tried in Hawaii, for approximately six weeks. The result was a $6,150,000 jury award in an extremely complex medical malpractice case. The Infant Plaintiff sustained numerous permanent injuries, including bilateral foot drop and diminished fine motor skills in her hands.

Infant Plaintiff, almost 15 at the time, was on vacation with her family in Hawaii when she became ill. The plaintiff contended that the defendant pediatric rheumatologist negligently embarked on a course of the administration of an excessive amount of steroids therapy when lupus was suspected. The plaintiff maintained that as a result, the infant plaintiff suffered steroid-induced myopathy that started with weakness in the legs, and progressed to total paralysis below the neck, only allowing plaintiff to communicate with her parents by blinking her eyes only for several months. The plaintiff went through extensive physical therapy, regained the use of her upper extremities, and the plaintiff, who was left with a bilateral foot drop, was ultimately able to walk a short distance with braces. The plaintiff further contended that the diminished fine motor skills in her hands are permanent in nature. The plaintiff has since completed high school, become a college student and generally ambulates on the campus by using a motor scooter.

The evidence disclosed that when the child developed a facial rash, unsteady gate and some slurred speech, the mother brought the child to the hospital. The defendant, an attending pediatric rheumatologist, conducted testing that showed elevated ANA levels and an MRI that depicted some areas of white matter density in the brain, made a diagnosis of lupus. The defendant embarked on a treatment course that entailed an initial dosage of one gm of glucocortoids a day for three days in a row that was followed by 40 mg of steroids for four days. The course was designed to be repeated for three subsequent weeks or "pulses." The initial pulse was administered while the plaintiff was an in-patient. The evidence reflected that the plaintiff responded very well, the unsteady gait and difficulties with speech essentially resolved and the blood work appeared to be returning to normal. The decision was made to administer the subsequent pulses on an outpatient basis. The plaintiff and her mother returned for the 2nd and 3rd pulses, and when the plaintiff complained of muscle weakness the day before the 4th pulse was administered, the mother, alarmed because she had researched the possible complications of steroids, including myopathy, on the Internet, declined to permit her daughter to undergo the treatment.

The plaintiff, who displayed signs of myopathy, was admitted and she became progressively weaker and ultimately was unable to move below the neck. The plaintiff was paralyzed in this manner for several months, and the evidence disclosed that during this period, the plaintiff communicated by blinking her eyes in response to questions. The plaintiff developed aspiration pneumonia during this period , required a tracheostomy and almost died during an extended period in the ICU. The plaintiff required a ventilator and feeding tube during portions of this period. The plaintiff gradually regained some use of her arms and legs and could sit in a wheelchair.

Approximately six months after the alleged negligence occurred at the end of Dec., 2003, and after the patient was able to sit in a wheelchair the patient was transferred to a rehabilitation hospital where she remained for approximately six months, undergoing extensive physical therapy. The plaintiff, whose permanent injuries included a bilateral foot drop, was able to walk a short distance with braces and can ambulate using a motor scooter. The plaintiff returned home, graduated high school, and began college where she has a 3.9 G.P.A.

The plaintiff's expert pediatric rheumatologist contended that the defendant administered significantly greater doses of steroids than accepted and the plaintiff maintained that the administration of such amounts is virtually unknown in the medical community. The expert maintained that because of the risks attendant to steroid administration, once the patient showed response from the first "pulse," the steroids should have been tapered off. The plaintiff also contended that because the defendant had only used this protocol on one patient prior to plaintiff she did not have sufficient experience with it to make an informed decision whether it should be continued after the positive response.

The defendant maintained that this protocol had been followed when she was a resident and presented two physicians involved in her training who supported this position. The plaintiff pointed to the testimony of the defendant that she had seen the regimen used only 4-5 times during her residency and that only one of these patients had lupus, which like the plaintiff, significantly involved the brain.

One of the physicians involved in the plaintiff's training testified that the protocol has been used approximately 200 times without complications. The plaintiff countered that such a number of cases was very small, especially when compared with the manner in which drugs are tested by the FDA where protocols under consideration typically go through a number of phases with progressively greater number of patients involved in each phase before final approval is given. The plaintiff also contended that the jury should consider that even when a drug has been studied for many years with large numbers of patients, adverse events are still reported, and maintained that the defendant's position that she acted appropriately and that the course seemed safe after being used on approximately 200 patients, should clearly be rejected.

The defendant also maintained that she would have ordered a lower dosage of steroids, but the mother would not consent to the defendant also administering Cytoxin, a chemotherapeutic agent also known to be effective in treating lupus, arguing that this factor justified that higher dosage of steroids. The plaintiff countered that the defendant's records reflected that the defendant had already planned to follow this protocol of steroid administration before the parents declined when the defendant suggested that Cytoxin be added.

The plaintiff maintained that because of the extensive physical therapy and the plaintiff's determination, she improved to the extent that she can excel at college and ambulate with the scooter. The plaintiff contended, however, that she will permanently suffer very significant difficulties with fine motor skills of the hands and will never be able to go up or down stairs without assistance. The plaintiff also contended that she faces a diminution in earning capacity of more than $900,000.

Mr. Russotti called various experts, including, a Pediatric Rheumatologist; a Muscle and Nerve Pathologist and Neurologist; a Rehabilitation Medicine Neurologist; a Life Care Planner; and an Economist.

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