On September 18, 2018, the FDA approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks of opioid pain medications to patients and health care professionals. This expanded REMS, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012. Additionally, the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011. Click title to continue reading...

On September 20, 2018, Maquet/Getinge initiated a worldwide recall of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient at altitudes above 3200 feet above sea level. Click title to continue reading...

On September 20, 2018, the FDA completed a review of all postmarketing reports of deaths and serious adverse events (SAEs) reported with the use of Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson’s disease psychosis. Click title to continue reading...

On September 20, 2018, a CDC study found that the U.S. burden of Alzheimer’s disease and related dementias (ADRD) will double by 2060. Alzheimer’s disease is the fifth most common cause of death for Americans ages 65 years and older. It is an irreversible, progressive brain disorder that slowly destroys memory and, eventually, a person’s ability to perform even the simplest tasks, such as bathing, feeding, and dressing. Click title to continue reading...

A nursing home patient with Alzheimer’s disease wandered unattended and died after drinking detergent the patient found in a kitchen cabinet. The patient’s estate filed a wrongful death suit against the nursing home in Michigan state court. The complaint alleged that the nursing home negligently understaffed the nursing home and improperly maintained, repaired, and secured the cabinet where the detergent was located. Click title to continue reading...

A pregnant patient met with an obstetrician/gynecologist (OB/GYN) for a physical exam and to discuss pregnancy related issues including testing for genetic abnormalities or mutations. The patient underwent routine, voluntary testing for cystic fibrosis (CF). The test revealed the patient was a carrier of the CF mutation. Along with the test results, the laboratory sent the OB/GYN a recommendation that carrier testing by mutation analysis and genetic counseling be offered to the carrier (i.e., the patient), relatives, and reproductive partners along with appropriate genetic counseling. Click title to continue reading...

While shoveling, spreading, and transferring a delivery of rocks, an employee of a mobile home and RV park felt burning back pain. The employee reported the incident to a coworker two days later. A week after the incident, the employee was terminated. Click title to continue reading...

As a special feature for our Premium subscribers, we have included this feature containing an illustrative complaint for a medical malpractice action alleging a failure to diagnose meningitis. In this illustrative situation, a woman presented at the emergency room with head trauma. The emergency room physician treated the wound and prescribed muscle relaxants and Tylenol and released the woman from the emergency room, even though the woman was experiencing dizziness, nausea, and a stiff neck. Click title to continue reading...