On April 24, 2015, the Texas Supreme Court dismissed claims against a compounding pharmacy and its individual pharmacists which alleged negligence in compounding a lipoic acid medication, finding that the defendants were health care providers entitled to the protections in the Texas Medical Liability Act (“TMLA”).
Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so. Federal law imposes several specific items to be included in the consent form. Where all pertinent risks, benefits and alternatives have been disclosed, and the patient signs the form, the patient is said to have given “informed consent.”
A patient injured in a clinical trial studying a new therapy for Parkinson’s Disease sued the manufacturer of the equipment used in the procedure. In addition to a claim of negligent design and manufacture of the equipment itself, the patient asserted that the manufacturer, as the sponsor of the clinical trial, was negligent in drafting and approving the informed consent documents that the patient signed to participate in the clinical trial. Can a manufacturer be liable for an improperly drafted consent form? Continue reading Clinical trial sponsors can be liable for inadequate consent forms
In a bold and seemingly unprecedented move, Aetna recently sued several California surgery centers for an alleged “fraudulent billing scheme”. The lawsuit alleges that the surgery centers induced physicians to refer patients to the surgery centers with promises that the patients would not have any financial responsibility for their coinsurance and deductibles. Aetna claims that the surgery centers then turned around and submitted charges for reimbursement that were artificially inflated driving up the cost of health insurance coverage.