Medical Risk Law Weekly News

Week of: February 25, 2019

IN THE NEWS


Increased Mortality Rate with Temporary Right Heart Pump

On February 4, 2019, the FDA issued a medical device safety letter to healthcare providers regarding interim post-approval study (PAS) results which suggested a higher mortality rate (73.3 percent) for patients treated with the Abiomed Impella RP System than the rate previously observed in the premarket clinical studies (17.4 percent). Click title to continue reading...


 
MEDICAL ALERTS


Doctor Markets Unapproved Device for Breast Implant Scar Tissue

On February 14, 2019, the FDA issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claimed can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. The warning letter also notified Dr. Berman of significant deviations from the FDA’s quality system requirements and current good manufacturing practices (CGMPs), including deviations from manufacturing processes intended to keep implants sterile. Click title to continue reading...



First Interoperable Insulin Pump for Diabetes

On February 14, 2019, the FDA authorized Tandem Diabetes Care Inc. to market the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences. Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters, or other electronic devices used for diabetes management. Click title to continue reading...



Initial Seven-Day Opioid Prescription Reduces Refills

On February 15, 2019, the CDC published a report that found that, for ten acute pain conditions commonly managed in primary care settings, the probability of obtaining a refill after an initial 7-day opioid analgesic prescription ranged from 11 percent (headache) to 41 percent (musculoskeletal injury), with refill probability less than 25 percent for most conditions. Click title to continue reading...


  CASE ALERTS


Failure to Replace, Repair Mitral Heart Valves

A vein from a patient’s heart was removed, resulting in the loss of blood supply to, and function of, the lower left lung. The same year, the patient had a pacemaker installed to address a history of atrial fibrillation. The patient received Social Security disability payments because atrial fibrillation made it impossible to work. The patient was a smoker. About eleven years after the pacemaker was installed, the patient gradually became less active and tired more easily. Click title to continue reading...



Lack of Informed Consent for Colon Excision During Appendix Surgery

A patient presented to the emergency room (ER) complaining of abdominal pain that had continued for several days. Diagnostic tests did not establish whether the patient was suffering from appendicitis. The ER doctor called in a surgeon for consultation and further evaluation. The surgeon recommended the patient undergo a diagnostic laparoscopic procedure with possible appendectomy. Click title to continue reading...



Hospital’s Anti-SLAPP Claim Against Patient Fails

A patient was seriously injured in a car accident. The patient was treated at a hospital. While the patient was still in the hospital, the hospital filed a hospital lien to give notice that the hospital asserted a lien on all causes of action or claims filed by or on behalf of the patient for damages arising from the injury for which the patient was admitted to the hospital. The hospital asserted an outstanding balance of $597,830.16 for extensive emergency care the hospital provided the patient over the course of three and a half weeks. Click title to continue reading...


FEATURE


Complaint: FTCA Claim–Hernia Repair

As a special feature for our Premium subscribers, we have included this illustrative complaint as guidance for plaintiff’s counsel in a federal tort action involving hernia treatment. In this illustrative situation, a man presented at a Veterans Administration (VA) hospital complaining of intense pain in the abdomen. The VA surgeon diagnosed the man with bilateral inguinal hernias and performed bilateral inguinal hernia repair surgery. During the surgery, the VA surgeon failed to appropriately isolate, protect, and preserve the spermatic cord structure on the patient’s left side causing extensive bruising and pain, and ischemia to the patient’s testicle, permanently damaging it. Following the surgery, the man suffered pain, swelling, and bruising, and complained to the surgeon and other VA hospital employees that he believed something was wrong with the hernia repair. The employees delayed undertaking appropriate diagnostic studies and consults to determine what, if anything, was wrong. After a family member of the man complained about the lack of care to a high-level VA official, an ultrasound was performed revealing a likely testicle infarction. A second surgeon performed a left oriectomy to remove the infarcted testicle and relieve the man’s pain. The man filed a claim under the Federal Tort Claims Act alleging negligence by the VA surgeon and VA hospital. Party identifying information has been redacted to protect privacy. Click title to continue reading...