Medical Risk Law Weekly News

Week of: February 04, 2019

IN THE NEWS


Manufacturing of Blood Pressure Drugs; Root Cause of Carcinogens

On January 25, 2019, the FDA issued a statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on the FDA’s ongoing investigation into impurities in blood pressure medicine and the agency’s steps to address the root causes of the safety issue. Click title to continue reading...


 
MEDICAL ALERTS


Recalled Breathing Circuits and Anesthesia Sets

On January 17, 2019, the FDA identified the Draeger Medical, Inc., recall of the VentStar and ID Breathing Circuits and Anesthesia Sets as a Class I recall. A Class I recall is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Click title to continue reading...



First Test to Diagnose Sexually-Transmitted Infection

On January 23, 2019, the FDA permitted Hologic Inc. to market the Aptima Mycoplasma genitalium Assay, a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). The Aptima Mycoplasma genitalium Assay is a nucleic acid amplification test, which detects M. gen. in urine, urethral, penile meatal, endocervical, or vaginal swab samples collected in a clinical setting, such as a doctor’s office or clinic. This is the first test authorized by the FDA to test for the M. gen. bacterium. Click title to continue reading...



Screening Organ Donors for Hepatitis, HIV

On January 25, 2019, the CDC published a report that found the number and proportion of organ donors at increased risk for transmitting hepatitis or human immunodeficiency virus (HIV) to recipients have increased since 2010, likely because of the epidemic of opioid overdose deaths. Compared with standard risk donors, increased risk donors were significantly more likely to have hepatitis B virus (HBV) and hepatitis C virus (HCV) infection. Click title to continue reading...


  CASE ALERTS


Failure to Treat Aqueductal Stenosis; Large Damages

A patient presented to the emergency room (ER) after becoming disoriented and confused, slurring speech, and subsequently suffering a head injury. The patient underwent an MRI. Lab tests were positive for benzodiazepines, which are drugs that could have caused some of the patient’s symptoms, including slurred speech. The ER physician referred the patient to a neurologist. Click title to continue reading...



Failure to Timely Diagnose Stroke and Administer tPA

A patient was admitted to the hospital and underwent a cardiac catheterization with stent placement performed by a cardiologist. The cardiologist performed the procedure without significant complication and expected to discharge the patient two days later. Click title to continue reading...



Vocational Expert Testimony Not Supported; Claimant Work Ability

A claimant was injured in an automobile accident. In the following months, the claimant experienced abnormal sensation in the hands and severe pain in the neck. Two doctors determined that the claimant was disabled from work as a consequence. The doctors believed that the unusual feeling in the claimant’s hands might be a result of carpal tunnel syndrome and that the neck pain might be attributable to herniated discs in the cervical spine. Click title to continue reading...


FEATURE


Complaint: Hernia Malpractice

As a special feature for our Premium subscribers, we have included this illustrative complaint as guidance for plaintiff’s counsel in a medical malpractice action involving a patient’s misdiagnosed hernia condition and unnecessary surgery. In this illustrative situation, the patient went to a surgeon’s office complaining of intense pain in the abdomen. The surgeon incorrectly diagnosed the patient as having a cyst that could be surgically removed and, while performing this unnecessary surgical procedure, the patient suffered excessive bleeding due to the hospital’s suction equipment failure. It took longer to stop the patient’s bleeding. The patient went into cardiac arrest due to the loss of blood and suffered permanent injuries. After a later diagnosis of the patient’s condition as hernia, not cyst, the patient sued the surgeon and the hospital. Party identifying information has been redacted to protect privacy. Click title to continue reading...