Medical Risk Law Weekly News

Week of: March 18, 2019

IN THE NEWS


Nasal Spray for Treatment-Resistant Depression Approved

On March 5, 2019, the FDA granted Janssen Pharmaceuticals, Inc., approval to market Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS). Click title to continue reading...


 
MEDICAL ALERTS


Risks Associated with Surgical Staplers, Implantable Staples

On March 8, 2019, the FDA issued a Letter to Health Care Providers to alert them that the FDA was aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples and to provide updated recommendations to help reduce risks associated with their use. The letter also included information about additional actions the FDA planned to address the devices’ safety, including issuing a draft guidance with labeling recommendations for manufacturers and holding a public advisory committee meeting to discuss whether the pathway for manufacturers to market surgical staplers for internal use was appropriate. Click title to continue reading...



Asbestos Contamination in Cosmetic Products

On March 5, 2019, the FDA provided an update on its assessment of contaminated Claire’s and Justice products. The FDA released new independent testing results that confirmed the presence of asbestos in product samples collected from Claire’s and Justice.  Additionally, the FDA issued a safety alert that warned consumers against the use of certain cosmetics sold by Claire’s. The FDA also announced new steps that the FDA would be taking, given existing limitations on the FDA’s cosmetic oversight authority, to better ensure the safety of cosmetic products. Click title to continue reading...



Deadly Staph Infections Threaten U.S.

On March 5, 2019, the CDC published a report that found that more than 119,000 people suffered from bloodstream Staphylococcus aureus (staph) infections in the United States in 2017. Nearly 20,000 died. Click title to continue reading...


  CASE ALERTS


Failure to Perform Cesarean Section on Breach Presentation; Expert

A patient presented to the hospital to give birth. The fetus was in a breech presentation, in which the buttocks and feet arrive first at the cervix. Approximately six hours after the infant was delivered, the infant died. Click title to continue reading...



Failure to Timely Perform Cesarean Section; Obstetrician Liability

A patient presented to the hospital to give birth. The patient’s labor slowed. An obstetrician performed an emergency bedside cesarean section. Subsequently, another obstetrician performed a bedside laparotomy and assisted in an emergency bedside hysterectomy. Twenty-five hours after being admitted to the hospital, the patient died from hemorrhagic shock; disseminated intravascular coagulation, widespread activation of the clotting cascade that results in the formation of small clots in small blood vessels throughout the body; and amniotic fluid embolism, when amniotic fluid or fetal material enters the maternal blood stream. Click title to continue reading...



Diagnostic Testing Facility Liable for Regulatory Noncompliance

A diagnostic radiologist became the medical director for a diagnostic testing facility that provided medical imaging services on a referral basis. Click title to continue reading...


FEATURE


Interrogatories: Malpractice for Failure to Warn of IUD Risks

As a special feature for our Premium subscribers, we have included these illustrative interrogatories as guidance for the physician’s counsel in a medical malpractice action involving an intrauterine device complication. In this illustrative situation, a woman consulted with a gynecologist about birth control. The gynecologist recommended the implantation of an intrauterine device (IUD) and the woman agreed. Following the insertion of the IUD, the woman suffered from side effects such as heavy bleeding and severe cramping and, after several months, requested that the gynecologist remove the IUD. The gynecologist was unable to remove the IUD and referred the woman to a specialist who also failed to remove the IUD despite several attempts. The woman was then hospitalized and underwent an open hysterectomy for the sole purpose of removing the IUD. The woman sued the gynecologist for malpractice and filed a products liability action against the manufacturer. Party identifying information has been redacted to protect privacy. Click title to continue reading...