Scalpel Weekly News

Week of: September 10, 2018

IN THE NEWS


Blood Pressure Drug Impurities Investigation

On August 30, 2018, the FDA issued a status report on its ongoing investigation into valsartan impurities and recalls. The FDA recently found that some generic versions of valsartan, an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure, contained an impurity, a chemical known as N-nitrosodimethylamine (NDMA). NDMA is a probable cancer-causing chemical found in trace amounts in water and some foods. NDMA is in a class of chemicals called “genotoxic impurities.” These chemicals are of special concern to global regulators because, unlike most impurities in drugs, they have the potential to cause harm at very low levels. Click title to continue reading...


 
MEDICAL ALERTS


Asthma Drug Recall; Incorrect Blood Pressure Drug in Bottles

On August 31, 2018, the FDA warned consumers and health care professionals about a recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019, NDC: 31722-726-30 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. Click title to continue reading...



21 Websites Marketing Unapproved Opioids

On August 28, 2018, the FDA announced it warned four online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers. The networks receiving warning letters include CoinRX, MedInc.biz, PharmacyAffiliates.org, and PharmaMedics. Click title to continue reading...



Steep and Sustained Increases in STDs

On August 28, 2018, the CDC released preliminary data that showed nearly 2.3 million cases of chlamydia, gonorrhea, and syphilis were diagnosed in the United States in 2017. This surpassed the previous record set in 2016 by more than 200,000 cases and marked the fourth consecutive year of sharp increases in these sexually transmitted diseases (STDs). Click title to continue reading...


  CASE ALERTS


Failure to Timely Remove Knee Prosthesis; MRSA Infection

An orthopedic surgeon performed a right total knee replacement, a surgical procedure requiring the implantation of a prosthesis. After the patient was discharged from the hospital, a physician assistant (PA) supervised by the orthopedic surgeon provided the patient with post-operative follow-up care. Click title to continue reading...



Failure to Diagnose Compartment Syndrome; Emergency Surgery

A patient presented to the emergency room (ER) complaining of left shin pain after playing basketball. The college athletic trainer had referred the patient to the ER due to suspected compartment syndrome based on the patient’s symptoms. A sports medicine fellow and the ER attending physician examined the patient. X-rays were taken. The patient was discharged with instructions to take an over-the-counter nonsteroidal anti-inflammatory drug and follow up with an orthopedist or sports medicine doctor. Click title to continue reading...



Insurer Chiropractor Pay Reduction; Unfair Trade Practice

An insurer sold or underwrote automobile insurance policies that included personal injury protection (PIP) to cover medical expenses incurred by a covered person as a result of a covered automobile accident. Over a period of four years, a chiropractic practice group treated patients who had PIP coverage under an automobile insurance policy issued or underwritten by the insurer. The insurer directed the chiropractic practice group to bill the insurer directly for treatment rather than the patient. The insurer accepted the chiropractic practice group’s bills as claims for payment of reasonable and necessary medical expenses under the patient’s PIP coverage. Click title to continue reading...


FEATURE


Complaint: Chiropractic Malpractice

As a special feature for our Premium subscribers, we have included this feature containing an illustrative complaint for chiropractic malpractice. In this illustrative situation, a woman sought treatment from a chiropractor due to a stiff neck. In the course of the chiropractic treatment, the woman suffered a back injury. The woman sued the chiropractor for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...