Trial ordered in University of Iowa medical study lawsuit
IOWA CITY (AP) — A trial has been ordered in a lawsuit that alleges doctors at University of Iowa Hospitals and Clinics conducted an experimental brain stimulation therapy that left a patient’s face paralyzed and then failed to get her proper treatment.
A judge rejected the hospital’s request to dismiss Tamara Stellmach’s medical malpractice lawsuit last week, ordering the case to proceed to a trial scheduled for Oct. 15.
District Judge Marsha Bergan said a jury should decide whether Stellmach was informed of the risks about her participation in the National Institutes of Health-funded study into whether biofeedback can improve bowel function. Jurors should also decide whether the therapy caused Stellmach’s facial paralysis and whether emergency room doctors failed to treat her properly, she ruled.
Stellmach contends she would have never agreed to participate if she had been warned of the risk.
University spokesman Tom Moore declined comment, citing a policy of not discussing pending litigation. The lead investigator on the study, Dr. Satish Rao, left the university and now directs the Digestive Health Center at Georgia Regents University.
Stellmach was a hospital call center employee in 2008 when she agreed to take part in the study, which involved experimental procedures to treat constipation and incontinence. The goal was to learn more about the nerve connections between the brain and the rectum and how biofeedback training may affect them.
Stellmach, 46, contends the procedure that left her injured is known as Transcranial Magnetic Stimulation, which involves using a coil to stimulate different parts of the brain using pulses of magnetic energy through the scalp. TMS is a relatively new treatment — typically used for depression — and little is known about its effectiveness, which techniques work best and whether it has long-term side effects, according to the Mayo Clinic.
Stellmach contends the therapy left her with a pounding headache, and she woke up the next morning largely unable to move most muscles in her face. She said she went to the hospital’s emergency room and was given an anti-viral drug, an eye patch and eye drops.
Her lawsuit contends the hospital should have also treated her with a steroid and immediately referred her for nerve decompression surgery, which she underwent 12 days later after her condition worsened. It restored her sense of taste but came too late to reverse her paralysis.
Hospital lawyers argue that the TMS was properly conducted and that her facial injuries could have been caused by prior health problems. They contend emergency room doctors acted appropriately in prescribing her an anti-viral drug, given a difference of opinion in the medical community on how to treat such a condition.
Stellmach’s case is built on the testimony of Bruce Gantz, head of the university’s department of otolaryngology, who performed her decompression surgery. He testified that he believes her paralysis could have been caused by the experiment, that doctors should have prescribed her a steroid, and that he would have been able to help her recover more had she been referred to him for surgery.
In her ruling, Bergan said “reasonable minds could draw different inferences and reach different conclusions” about the cause of Stellmach’s injuries. Jurors should determine what weight and credibility to give to the conflicting testimony in determining whether the hospital was negligent and failed to obtain informed consent, she ruled.
Stellmach and her husband filed the lawsuit in 2010, seeking damages for pain and suffering and loss of income. They referred questions Tuesday to their attorney, who didn’t immediately return a message seeking comment.