Yesterday, the FDA issued a safety alert for Bard Recovery and Bard G2 filters, inferior vena cava (IVC) filters, manufactured by C.R. Bard. These filters are small devices that are implanted in to the inferior vena cava, the main blood vessel that returns blood from the lower half of the body, to prevent pulmonary embolism. The filters prevent blood clots from reaching the lungs where they would become fatal. Over the last five years, there have been 921 adverse event reports involving IVC filters - 328 cases where the device migrated in the body, 146 cases involving a detachment of a device component, 70 cases involving perforation, and 56 cases where the filter fractured. According to the FDA, many of these events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of a blood clot or pulmonary embolism has subsided.
Earlier this week, a panel of the Pennsylvania Superior Court issued an opinion for publication in Lance v. Wyeth, a pharmaceutical case in which the plaintiff alleged that her use of Wyeth’s obesity drug, Redux, caused the development of Primary Pulmonary Hypertension (PPH) and ultimately death. The Superior Court’s opinion is significant for consumers and plaintiffs lawyers because the opinion affirmatively recognizes for the first time the viability of a claim in Pennsylvania for negligent design defect.
An article published on July 31, 2010 in the New York Times revealed that during the past year over 400 patients nationwide have received a higher-than-expected dose of radiation during a specific CT scan, called a CT brain perfusion scan, which has led to hair loss in a circular pattern around the head, headaches, memory loss, and confusion.
This article comes after the federal Food and Drug Administration (FDA) announcement in April 2010 that it was taking steps to reduce overdoses and other errors in radiation therapy by strengthening the approval process for new radiotherapy equipment. The FDA announcement followed several other reports and studies during the last 10 months that have shed light on the prevalence of radiation overexposure during various types of CT scans. Such overexposure can lead to an increased risk of certain cancers and brain tumors in addition to other symptoms of radiation exposure such as hair loss, erythema, nausea, vomiting, headache, fatigue, weakness, and fever.