Scalpel Weekly News

Week of: January 22, 2018

IN THE NEWS


Lead Test Blood Collection Tube Manufacturer Violations

On January 11, 2018, the FDA issued a warning letter to Becton Dickinson & Company (BD) that cited several violations of federal law, including marketing significantly modified versions of certain BD Vacutainer blood collection tubes without the required FDA clearance or approval and failing to submit medical device reports to the FDA within the required timeframe.  Click title to continue reading...


 
MEDICAL ALERTS


Anaphylaxis or Hypersensitivity from Chemotherapy-Induced Nausea Drug

On January 16, 2018, Tesaro, Inc., issued a letter to inform health care providers to be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration. Click title to continue reading...



First Drug Treatment for Breast Cancer with BRCA Mutation

On January 12, 2018, the FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation. This is the first drug in its class (PARP inhibitor) approved to treat breast cancer. Click title to continue reading...



Risky Antibiotics Given to Privately Insured Pregnant Women with Urinary Infections

On January 12, 2018, the CDC published a report about health care providers dispensing to pregnant women antibiotics that have a risk of birth defects. Use of sulfonamides and nitrofurantoin during early pregnancy carries a risk of birth defects, including anencephaly (a serious birth defect in which a baby is born without parts of the brain and skull), heart defects, and orofacial clefts (cleft lip and cleft palate; birth defects that occur when a baby’s lip or mouth do not form properly during pregnancy). Click title to continue reading...


  CASE ALERTS


Material Fact Whether Steroid Injections Caused Tendon Rupture

A man underwent two steroid injections. The doctor who performed the injections injected one dose in the area of the thumb joint. Approximately two weeks later, the doctor injected a dose of steroids into the man’s elbow. Subsequently, the man sustained a ruptured tendon in the forearm near the injection site. Click title to continue reading...



Wrong Blood Test Result Reported to Patient; Defense Verdict

A woman suffered from chronic neck and back pain. The woman saw a doctor monthly for approximately 18 months to reassess the woman’s neck and back pain and prescribe pain medication. Click title to continue reading...



Officer Denied Accidental Disability Retirement; Return to Full Duty

A police officer sustained two line-of-duty (LOD) injuries in one year. Following each injury, the officer returned to full duty. The officer sustained a third LOD injury the following year. The officer’s treating physician diagnosed the officer with back sprain, contusion of the coccyx, and tendinitis of the right wrist. At a follow-up appointment two months after the injury, the officer’s treating physician diagnosed the officer with mild herniation, nerve impingement, and spondylosis—meaning degeneration of the spinal column from any cause. Click title to continue reading...


FEATURE


Checklist: Physician Deposition; Experimental Treatment

As a special feature for our Premium subscribers we have included this feature containing a checklist to use in preparing to depose a physician regarding malpractice in the administration of an experimental treatment. In this illustrative situation, a man participated in a physician’s experimental treatment study and suffered an infection as a result of the experimental surgery. The man sued the physician for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...