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Mike Damaso
Mike Damaso
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Little Recourse for Patients Injured in Drug Trials

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There was an interesting article in the Wall Street Journal this weekend regarding the problem of patients injured by new drugs during clinical trials having little to no recourse. The article blames the problem on several factors including: 1. Confusing and vague consent forms; 2. Lack of clarity as to which research entity is responsible for subsequent care; 3. Uncertainty as to how much that entity will pay and under what circumstances it is obligated to pay; and 4. Difficulty in trying to separate what was directly caused by the trial from the natural progression of the participant’s disease. The article also blames the lack of legal, regulatory, and governmental oversight. It reports that Federal Law does not require researchers to compensate participants injured in clinical trials. It only requires that the consent forms set out whether compensation exists for research related injuries in trials that involve more than a “minimal risk.”

The article notes two case specific examples. In one, an 18 year old died when involved in a gene-therapy trial at the University of Pennsylvania. The attorney who represented the family of the boy was able to obtain a settlement in the case for an undisclosed amount. That attorney is quoted in the article as saying many lawyers are reluctant to get involved in clinical trial injury cases because they worry that the consent forms protect drug companies and research institutions from liability. But, the attorney from the Penn case shows that it is possible to find flaws in the informed consent process and has handled 13 clinical trial cases since, with 11 partial or full settlments.

The other case noted in the article involved a 71 year old retired kindagarten teacher who suffered from Parkinson’s and was talked into a clinical trial by a treating neulologist at UCLA. The trial involved surgically implanting an experimental drug called Spheramine into her brain. Prior to the surgery, she could drive, cook, and care for herself. Immediately following the surgery, she was unable to sit up straight in a chair. Following the surgery, her balance decreased and she was restrained to a seatbelted wheelchair. she hallucinated frequently, and her cognitive skills diminished considerably, according to her family.

Who was the proper party to be financially responsible? The clinical trial was initiated by the treating neurologist at UCLA. The drug Spheramine was originally developed by Titan Pharmaceuticals, Inc. But, Titan entered into a partnership to develope the drug with a company called Berlax, Inc, which is the U.S. division of the German drug company, Scherring AG. Pre-operative testing was done at UCLA. The procedure was to be performed at Stanford University’s medical center. But, the surgery was actually perfrormed at Tampa General Hospital by University of South Florida doctors. USF, Tampa General, and Berlex, Inc. all provided consent forms for the patient to sign. These consent forms were not consistent as to who would be responsible for future medical care in the event of an injury.

The Institute of Medicine has recommended a “no-fault compensation system” for individuals injured during clinical trials. Of course, the article reports the goal of a no fault system would be to resolve claims quickly without having to resort to lawsuits.