Study Participant Says She was Never Warned of Brain Injury Risk

Study Participant Says She was Never Warned of Brain Injury Risk

A participant in a National Institutes of Health-funded study at the University of Iowa Hospitals and Clinics was hoping she could obtain some relief from a bowel condition while helping the advancement of science, but she ended up with a brain injury that left most of her face paralyzed. When she sought treatment for the paralysis the day after the experimental treatment, moreover, emergency room staff failed to give her the treatment that could have reversed the damage, she claims in court.

Attorneys for the hospital sought to have her claim thrown out of court, arguing that the experimental treatment was performed properly and that her facial paralysis might be the result of a preexisting condition. Furthermore, they argued, her ER treatment met the generally accepted standard of care. However, the doctor who performed the treatment believes the paralysis might well have been caused by the treatment — and that with proper ER treatment, her paralysis might have been reversible.

The experimental treatment involved is known as Transcranial Magnetic Stimulation. In TMS, an electrical coil on the scalp transmits magnetic energy to the brain. The relatively new treatment is thought to be effective in a variety of conditions ranging from clinical depression to Parkinson’s disease. As yet unknown, however, is how effective TMS is, and for what conditions, along with its long-term side-effects and the most effective technique. In this study, researchers were studying its affect on bowel function.

The woman agreed to participate in the study, but she now says she was never warned of any risk of a brain injury.

The treatment, she says, left her with an excruciating headache. The next day, she awoke without her sense of taste and unable to control most of the muscles in her face. She went to the ER and was given eye drops, an eye patch, and an anti-viral drug. Twelve days later, she underwent nerve decompression surgery, but while she regained her sense of taste, it was too late to correct the paralysis.

She and the doctor who performed the TMS believe that if she had been given a steroid, it would have reduced the pressure on her brain and nerves, stabilizing the swelling and making the condition treatable.

The judge refused to throw out the medical malpractice suit, ruling that the questions of whether the woman had been adequately warned of the potential risks, whether her paralysis is the result of a TMS-related brain injury, and whether her ER treatment was appropriate should be left to a jury to decide. “[R]easonable minds could draw different inferences and reach different conclusions,” she ruled.

Source: Clinton Herald, “Trial ordered in medical study lawsuit,” Associated Press, Aug. 14, 2013

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