Medical Risk Law Weekly News

Week of: March 11, 2019

IN THE NEWS


CanaRx Unapproved, Misbranded, Unsafe Drugs; FDA Warning

On February 28, 2019, the FDA posted a warning letter to CanaRx for facilitating the distribution of unapproved drugs and misbranded drugs to U.S. consumers. These drugs are potentially dangerous to U.S. consumers. Click title to continue reading...


 
MEDICAL ALERTS


Risk of Blood Clots, Death with Rheumatoid Arthritis Drug

On February 25, 2019, the FDA alerted the public that a clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). The FDA has not approved this 10 mg twice daily dose for RA. A 10 mg twice daily dose was approved only in the dosing regimen for patients with ulcerative colitis. Click title to continue reading...



Risky Robotically-Assisted Surgeries for Mastectomy and Cancer

On February 28, 2019, the FDA issued a safety communication regarding using robotically -assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer. The FDA advised healthcare providers that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established. However, the FDA became aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy. Click title to continue reading...



Measles Outbreak Under Stricter Immunization Requirements

On March 1, 2019, the CDC published a report that described a measles outbreak in California and Nevada after California implemented stricter immunization requirements. Since California Senate Bill 277 (SB277) went into effect in 2016, children entering school in California may no longer receive exemptions from immunization requirements based on parental personal beliefs. Click title to continue reading...


  CASE ALERTS


Failure to Diagnose Rectal Cancer Recurrence; $15 Million Award

A patient in remission from rectal cancer visited a gastroenterologist complaining of constipation. The patient underwent a colonoscopy, which revealed a large mass. The gastroenterologist referred the patient for an abdominal and pelvic CT scan. Click title to continue reading...



Failure to Diagnose Stroke; Verdict for Physician

A patient became ill and received permission from the halfway house where the patient resided to go to a clinic for medical care. The patient complained of headache, neck pain, and dizziness. The patient was diagnosed with headache and acute sinusitis, prescribed one medication, and returned to the halfway house. Click title to continue reading...



False Light Invasion of Privacy; Alcohol Abuse Disclosed to Employer

A patient paid $10,000 in advance for ten treatment sessions at a mental health clinic for the treatment of anxiety and post-traumatic stress disorder (PTSD). The patient received ten intravenous nicotinamide adenine dinucleotide (NAD) treatments. NAD is a cofactor found in all living cells that participates in multiple aspects of cellular metabolism. The patient did not receive any individualized or group therapy, psychotherapy, hypnotherapy, or counseling. The therapist billed the patient’s health insurance company for services. Click title to continue reading...


FEATURE


Medical Records Checklist: Malpractice-IUD and Ectopic Pregnancy

As a special feature for our Premium subscribers, we have included this checklist as guidance for counsel’s medical records review for a medical malpractice action involving an intrauterine device complication. In this illustrative situation, a woman consulted with a gynecologist about birth control. The gynecologist recommended the implantation of an intrauterine device (IUD) and the woman agreed. Click title to continue reading...