Recent News
FDA Increases Invokana Warnings
In September, the Food and Drug Administration (FDA) strengthened a warning that linked diabetes drug Invokana to an increased risk of bone fractures. The warning came as the result of various separate clinical studies showing that the medication reduced bone density in patients, and caused severe fractures. The FDA will continue to monitor Invokana and…
Jury Awards $28 Million in Stern v. Woodholme Gastroenterology, P.A., et al
On May 12, 2011, Gary Stern was admitted as a patient to Sinai Hospital with severe left upper abdominal pain. The consulting gastroenterologist (GI) did not consider any upper intestinal issues to be the cause of Mr. Stern’s pain, and attributed his illness to a chronic history of Crohn’s disease. In fact, Mr. Stern had an ulcer…
Class I Recall Issued for Teleflex Endobronchial Tube
On June 1, 2015, Teleflex Medical notified consumers of an Urgent Medical Device Recall relating to its endobronchial tube, as well as corresponding parts and accessories. According to the recall notification, tubes and parts manufactured and distributed between October 2013 and May 2015 may be defective. The recall comes after the company received consumer complaints…
New Survey Reveals Robotic Surgery is Linked to Hundreds of Deaths
A new survey—compiled of information from researchers at the University of Illinois at Urbana-Champaign, the Massachusetts Institute of Technology and Chicago’s Rush University Medical Center—reveals that surgical robotic devices have been linked to at least 144 deaths, over 1,400 injuries and 8,061 malfunctions in a period of 14 years. The survey was based on information…
Power Morcellators Now Being Investigated by the FBI
Laparoscopic power morcellators, which are designed to cut and slice fibroids, have also been found to spread cancer in women. As a result, in November 2014, the Food and Drug Administration mandated that the device carry a black box warning, the highest warning of risk that the agency provides. Johnson & Johnson, the largest manufacturer…