When undergoing a medical procedure, patients usually trust that their doctors and other attending physicians and staff use proper care. What most patients do not usually think about is whether or not the devices that the doctors are using have been approved by the U.S. Food and Drug Administration.
Recent Circuit Court of Appeals ruling
SFGate.com recently reported that the Ninth U.S. Circuit Court of Appeals in San Francisco, California ruled that doctors who use proper care to treat patients cannot be sued for using devices or drugs that have not been approved by the FDA.
The suit was a proposed class action brought on behalf of patients who underwent Lasik surgery for farsightedness before its FDA approval in 2006. Until 2006, the lasers were only approved to correct nearsightedness.
Although none of the patients were injured, they claimed that they were made unwitting subjects of medical experiments and were defrauded when their doctors used the lasers in ways that had not been approved by the FDA.
The doctors argued that they have the discretion to use devices and medications however they find appropriate to treat their patients.
The federal judge dismissed the suit because, under a 1978 California law, a patient's consent to conduct a medical experiment is only required in research projects and is not required during therapeutic treatment.
The patients appealed, but the circuit court judge affirmed the federal court's holding, stating that because the lasers were being used for therapeutic purposes and did not cause harm to the patients, the rights of the patient's were not violated by the doctor's off-label use. The circuit court judge also stated that doctors are not required under federal law to tell patients whether or not the medical devices being used have been approved for a particular use.
If one of the patients would have been harmed by the doctor's wrongful use of the lasers, it is possible that the patient could have sued the doctor for medical malpractice for negligent treatment.
Overview of negligence in a medical malpractice claim
A doctor can be held legally liable for injuries caused by medical malpractice under the theory of negligence. When a medical device is involved, a doctor or other medical professional could be held liable for the negligent prescription of a medical device or of a medication if he or she gave the patient an incorrect medication or dosage or ignored the manufacturer's instructions, which resulted in injury to the patient.
To prove negligence, the plaintiff must prove all of the following:
- There was a duty owed by the doctor to the patient because of a doctor/patient relationship.
- The doctor deviated from the applicable standard of care and thus breached the duty owed to the patient.
- The deviation from the standard of care caused injury to the patient.
- An injury actually resulted.
Someone who has been harmed by a doctor's practice or by a device used by a doctor should consult with a skilled medical malpractice attorney.
Contact an Orange County Personal Injury Lawyer
If you or a loved one has been injured as a result of the carelessness of a medical professional, contact the Law Office of Marshall Silberberg as soon as possible. You may be entitled to significant compensation for damages including medical bills, pain and suffering, lost income, and more. Consultations are provided free of charge - call now.