Scalpel Weekly News

Week of: August 13, 2018

IN THE NEWS


Risks of Transmucosal Immediate-Release Fentanyl Pain Products

On August 1, 2018, the FDA announced that it will host a public advisory committee meeting to review data from the most recent assessment of the Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) for transmucosal immediate-release fentanyl (TIRF) products. TIRF medicines include Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal soluble film. Click title to continue reading...


 
MEDICAL ALERTS


First Treatment for Adrenal Tumors

On July 30, 2018, the FDA granted Progenics Pharmaceuticals, Inc. approval to market Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed, have spread beyond the original tumor site, and require systemic anticancer therapy. This is the first FDA-approved drug for this use. Click title to continue reading...



Antibiotic Increases Risk of Blood and Lymph Cancer Relapse

On August 3, 2018, the FDA warned health care providers that the antibiotic azithromycin should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. Click title to continue reading...



Schools Found Not Prepared for Various Emergencies

On August 3, 2018, the CDC published a report that found no increase from 2006 to 2016 in the percentage of school districts that have a comprehensive plan to address crisis preparedness, response, and recovery. About one in four school districts does not have plans to address mental health needs and family reunification after an emergency. One in three school districts does not have plans to address an infectious disease outbreak. Click title to continue reading...


  CASE ALERTS


Inadmissible Expert Testimony that Accutane Caused Crohn’s

Patients who used Accutane (isotretinoin), a prescription drug used in the treatment of nodular acne, developed Crohn’s disease, a form of irritable bowel disease characterized by inflammation and ulcers in the digestive tract that can result in abdominal pain and other complications. The exact cause of Crohn’s disease is unknown. Click title to continue reading...



Unqualified Experts in Failure to Timely Administer tPA Claim; Clots

A patient was admitted to the hospital due to the new onset of hypertension, malaise, fevers, night sweats, Raynaud’s phenomenon, and a positive antinuclear antibody (ANA) test. In Raynaud’s phenomenon, also called Raynaud’s syndrome, smaller arteries that supply blood to the skin constrict excessively in response to cold, limiting blood supply to the affected area. ANA tests help evaluate a patient for autoimmune disorders. Click title to continue reading...



Employee Failed to Provide Sufficient Evidence of Pain Disability

An employee’s long-term disability benefits were governed by the employer’s employee welfare benefit plan. The plan defined disability as meaning the employee was prevented from performing one or more of the essential duties of (1) the employee’s occupation during the 180-day elimination period; (2) the employee’s occupation for the 24 months following the elimination period, and as a result the employee’s monthly earnings were less than 80 percent of the employee’s predisability earnings; and, (3) after that, any occupation. The plan explained that it was the claimant’s responsibility to submit continuing proof of disability. Click title to continue reading...


FEATURE


Plaintiff’s Interrogatories: Urological Negligence

As a special feature for our Premium subscribers, we have included this feature containing an illustrative complaint for the negligence of a urologist in diagnosing a patient’s urological disorder. In this illustrative situation, a young woman sought treatment from a urologist for urinary incontinence. The urologist diagnosed the woman with temporary urinary incontinence caused by obesity and diet. The woman returned to the urologist after three months and was told by the urologist the incontinence would go away when the woman lost more weight. The woman sought a second opinion and was diagnosed with cancer in the urinary tract. Due to the delay in this diagnosis, the tumor had spread to the woman’s uterus. As a result, the treatment involved a hysterectomy which left the woman unable to bear children. The woman sued the urologist. Click title to continue reading...