Medical Risk Law Weekly News

Week of: January 28, 2019

IN THE NEWS


Nationwide Recall of Blood Pressure Drug; Carcinogen

On January 18, 2019, Prinston Pharmaceutical Inc., d/b/a Solco Healthcare LLC., recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. Click title to continue reading...


 
MEDICAL ALERTS


Over-the-Counter Naloxone Developed to Reduce Opioid Overdose Deaths

On January 17, 2019, the FDA announced the unprecedented steps the FDA took to help drug companies submit new drug applications or supplements for over-the-counter (OTC) naloxone. The FDA developed a model Drugs Facts label and conducted label comprehension testing, steps that are usually conducted by drug companies, not the FDA. Click title to continue reading...



Nationwide Recall of Anesthesia Drug; Glass Particles

On January 8, 2019, Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd., recalled three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder). The Vecuronium Bromide for Injection contains a particulate matter identified as glass. Click title to continue reading...



Gastroschisis Birth Defect Linked to Prescription Opioids

On January 18, 2019, the CDC published a report that found, between 2011 and 2015, gastroschisis prevalence was 10 percent higher than the prevalence between 2006 and 2010. An analysis found a higher prevalence of gastroschisis in areas where opioid prescriptions rates were high, supporting epidemiologic data suggesting an association between opioid use during pregnancy and gastroschisis. Click title to continue reading...


  CASE ALERTS


Failure to Diagnose Wilson’s Disease; Malpractice; Damages

A patient started seeing a counselor for anxiety and depression. At about the same time, the patient consulted with a primary care physician. The primary care physician ordered lab tests that revealed the patient had elevated levels of liver enzymes. The primary care physician diagnosed the patient with mononucleosis. Click title to continue reading...



Insufficient Support for Expert’s Causation Conclusion

A patient was diagnosed at a young age with a neurological disorder. Part of the patient’s treatment was to receive intrathecal baclofen, a muscle relaxant used to treat muscle spasms administered by a catheter and pumped into the thecal sac located around the spinal cord. A neurosurgeon replaced the patient’s pump, but not the catheter connected to the pump. Click title to continue reading...



Health Insurance Cross Plan Offset Unreasonable; Reimbursement

An administrator administered thousands of health insurance plans. In the course of processing millions of claims for benefits, the administrator occasionally erroneously overpaid service providers. The administrator could generally recover those overpayments from in network providers because it had agreements with those providers that allowed it to offset the overpayment by withholding the overpaid amount from the subsequent payments to that provider. Click title to continue reading...


FEATURE


Risk Manager Checklist: Physician Duty-Weight Loss Procedures

As a special feature for our Premium subscribers, we have included this checklist as guidance for risk managers of hospitals, outpatient clinics, and other health facilities when determining the appropriate policies, procedures, and training to put in place in order to reduce the risk of malpractice and negligence claims related to weight loss procedures, such as gastric bypass surgery and tumescent liposuction. Click title to continue reading...