Q: I was given an experimental drug at a hospital without my consent and it resulted in serious medical issues, can I sue?
In 2016 I was taken to OHSU because I had contracted necrotizing fasciitis from the Clackamas River. They knew that my legs needed to be amputated in order to save my life but instead they gave me an experimental drug without my consent to see if it would stop the rate of the infection. It did not. I fell into a coma and as a result of sepsis, I lost 9 of my fingers. They amputated my fingers before they even amputated my infected legs because the protocol of the study was not to amputate the infected area for 7 days. Had they just amputated when I was first brought in, I wouldn't have lost my fingers and maybe not both my legs. Is it the FDA or the hospital who I would be at fault and am I even able to sue?
A:
If OHSU deviated from the standard of care by not amputating your legs promptly, which is a known effective treatment for necrotizing fasciitis, you might have a case for medical malpractice. The experimental drug trial's protocol, if it delayed necessary treatment, could be seen as negligence if it's determined that the protocol was not in your best interest medically.
You mention that the experimental drug was administered without your consent. In medical practice, informed consent is crucial, especially for experimental treatments. If there was no consent or if you were not in a state to give informed consent, and no legal guardian or next of kin provided it, this could constitute a breach of medical ethics and potentially be actionable.
If you were part of a clinical trial, the responsibility might be shared between OHSU, the drug's manufacturer, and possibly the FDA if there were regulatory oversights. However, the FDA's role is primarily regulatory; they approve trials but don't manage individual patient care or consent. The hospital and the trial sponsors would typically be more directly liable for issues related to patient treatment within the trial.
You'll need to demonstrate through expert testimony that the delay in amputation was against medical standards for treating necrotizing fasciitis. Documentation or witness testimony regarding the lack of consent for the experimental drug will be crucial. Oregon has specific laws regarding medical malpractice, including statute of limitations which might affect when you can file a lawsuit. Given the date of your incident was 2016, you'd need to check if you're still within the legal timeframe to file a claim.
Given the complexity, especially involving experimental treatments and clinical trials, consulting with a medical malpractice attorney in person, particularly one with experience in cases involving experimental drugs or clinical trials, would be advisable.
Remember, while this outlines potential legal pathways, each case's specifics can alter the approach. Legal advice tailored to your situation, considering all facts and Oregon's legal landscape, would be necessary for a definitive course of action. Good Luck
Tim Akpinar agrees with this answer
1 user found this answer helpful
A: This is a horrible situation, and I hope that you are finding ways to manage despite the limitations. There could be liabiity for acting without your consent or perhaps outside of the scope of what is accepted standard of practice in the community. Bad outcomes don't automatically equate to liability. Medical professionals often act with the best intent to save the lives of people while minimizing loss of quality of life. Judgment calls are often made. If the Judgment call was outside the standard of care and caused damage (harm), then you have a cause of action for that laspe in professional judgment, as here, you argue that your fingers and possibly legs could have been saved. On the otherhand, you mentioned that this occurred in 2016. There are definite time frames for filing claims. Genrally, the time frame for filing a negligence claim is 2 years from the date of incident. You may be given additional time if you did not know or reasonably could not have known about the liability until you discovered it. But, the statute of ulitmate repose (absolute final date to file a claim) is 5 years for medical malpractice and 10 years for most other claims. You are still within the 10 year period. Since OHSU is a public instituion, you will need to satisify the tort claim act. This requires specific notice to the governmental body within 180 days of the date of injury or loss. This is if there is something that reasonably prevented you from knowing aout the liability. You should seek the advice of a highly experienced medical malpractice attorney who has experience with suing the government--as well as someone who have experience suing drug manufacturer, who may be liable, if they provided the wrong instructions to the medical professionals about the protocols in your situation. This response to to provide you some direction, but no intended to form an attorney-client relationship or for you to rely on in making any decissons about how you move forward with your case. I cannot properly address or evalute your legal claim from your question. You need to consult a attorney who can provide guidance on your particular case after asking you detailed questions. Mr. Knickerbocker III answered the question extremely well. I would just add that in addition to this, that you also consider whether the treatment providers were acting agressively in an emergency state to save your life. Hindsight is also always 20/20 and if you intent to sue the people who were desperately trying to save your life, it is an emotional and challenging endeavor. I wish you the best moving foward, and I hope that you have been able to adjust and focus on the things you can do--not what you can't. In the meantime, you should seek out the best medical malpractice and pharmaceutial attorney to discuss your options if you still want to pursue a recovery for your loss. Best wishes.
Tim Akpinar agrees with this answer
1 user found this answer helpful
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