Medical Risk Law Weekly News

Week of: April 29, 2019

IN THE NEWS


First Medical Device for Treatment of ADHD

On April 19, 2019, the FDA authorized NeuroSigma to market the Monarch external Trigeminal Nerve Stimulation (eTNS) System, the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only Monarch eTNS System is indicated for patients ages seven to 12 years old who are not currently taking prescription ADHD medication. This is the first non-drug treatment for ADHD granted marketing authorization by the FDA. Click title to continue reading...


 
MEDICAL ALERTS


Nationwide Recall of Mislabeled Fentanyl Patch

On April 19, 2019, Alvogen, Inc. recalled two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches. Cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. Click title to continue reading...



Measles, Mumps, Rubella Vaccine Safe and Effective

On April 22, 2019, in response to the increasing number of measles outbreaks, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, issued a statement on the FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine. The number of measles outbreaks is increasing in communities across the country, including in New York, New Jersey, Washington, California, and Michigan. Click title to continue reading...



Increasing Lyme, Other Tickborne Diseases

On April 22, 2019, the CDC published a new resource for tick season with the latest information about the increasing number of reported tickborne illnesses, newly discovered disease-causing germs, expanding ranges of ticks, and a new tick species in the US. Click title to continue reading...


  CASE ALERTS


Failure to Diagnose Uterine Cancer; Expert Not Qualified

A patient discussed not feeling well with a colleague, a board certified surgeon. The patient reported feeling bloated and constipated and experiencing pelvic pressure. The surgeon ordered an abdominal CT scan. The surgeon’s notes stated that a colonoscopy may be indicated for possible identification of an obstructing lesion of the colon causing the symptoms. By the time the CT scan was signed by a radiologist and available for review, the patient had moved to a new city. Click title to continue reading...



Failure to Admit Patient to Hospital

A patient presented to a health clinic complaining of abdominal pain, fever, chills, and other symptoms. A nurse practitioner (NP) ordered a series of tests. The test results showed that the patient had unusually high levels of white blood cells and other abnormalities. These results led the NP to believe that the patient had an infection and needed to be hospitalized. Click title to continue reading...



Hospice Provider Owes Medicaid $1.9M for Unsubstantiated Claims

A hospice provider provided outpatient hospice care to Medicaid beneficiaries. As a Medicaid provider, the hospice provider was required to maintain auditable records that would substantiate the claims submitted to Medicaid. Failure to do so would result in a request to refund to Medicaid any money received for non-substantiated services. Click title to continue reading...


FEATURE


Expert Examination: Failure to Diagnose Rheumatoid Arthritis

As a special feature for our Premium subscribers, we have included illustrative questions for direct examination of an expert witness for the plaintiff in a medical malpractice action involving the patient’s misdiagnosed rheumatoid arthritis. In this illustrative situation, a young man presented to his primary care physician on multiple occasions, complaining of fatigue, as well as pain, swelling, and stiffness in various joints. Click title to continue reading...