Defibrillators are designed to save the life of someone in cardiac arrest. However, they do not always function as intended. In fact, the U.S. Food and Drug Administration (FDA) reports that it has received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of the medical devices. According to the FDA, [...] Read more »
Displaying all posts for ‘Medical Devices’
Jury Awards $11.1 Million in Vaginal Mesh Lawsuit
by vaagelaw April 29, 2013 » Add the first comment.
Johnson & Johnson has been ordered to pay $11.1 million in a New Jersey vaginal mesh lawsuit. The jury award includes $7.76 million in punitive damages. As we have previously discussed on this San Diego Injury Blog, an FDA review of industry literature and adverse event reports found little evidence that vaginal mesh implants improve [...] Read more »
FDA Proposing New Rules For Metal-On-Metal Hip Implants
by vaagelaw April 25, 2013 » Add the first comment.
Research shows that metal-on-metal hip implants are failing at an alarming rate. Last year, these safety concerns prompted the Food and Drug Administration (FDA) to order manufacturers of the medical devices to study how frequently they were failing and to examine the health implications for patients. As we previously discussed on this San Diego Product [...] Read more »
Medical Device Recall Alert: LifeScan Recalls Blood Glucose Meters
by vaagelaw April 19, 2013 » Add the first comment.
As San Diego product liability lawyers, we want to share an important medical device recall. LifeScan, Inc. has announced it will recall all 90,000 of its OneTouch® Verio®IQ blood glucose meters in the United States. According to Johnson & Johnson, the devices malfunction at extremely high blood glucose levels of 1024 mg/dL and above. When [...] Read more »
Sterility Problems at Compounding Pharmacy Leads to Drug Recall
by vaagelaw April 18, 2013 » Add the first comment.
The safety practices of another U.S. compounding pharmacy are now (literally) under a microscope. The Food and Drug Administration (FDA) announced the recall of the cancer drug Avastin after five patients contracted eye infections that may cause blindness. According to the FDA, Avastin syringes produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) were being used [...] Read more »
Johnson & Johnson Medical Device Subject to Class I Recall
by vaagelaw March 4, 2013 » Add the first comment.
DePuy Orthopaedics, Inc., a Johnson & Johnson Company, recently announced a class I recall of its Limb Preservation System (LPS) Diaphyseal Sleeve. The medical device is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. As San Diego injury attorneys, the recall is concerning because class I recalls [...] Read more »
Study Raises Questions About Safety of Heart Devices
by vaagelaw November 12, 2012 » Add the first comment.
A new study raises questions about whether heart devices are better than existing treatments. Given the risks associated with having surgery to implant stents, defibrillators, and heart pumps, the results are concerning. After examining information from the U.S. Food and Drug Administration on all high-risk device approvals from 2000 to 2011, the researchers found that [...] Read more »
FDA Calls for Additional Monitoring of Defective Heart Devices
by vaagelaw August 31, 2012 » Add the first comment.
The Food and Drug Administration is calling for additional studies regarding the safety of recalled heart devices made by St. Jude Medical. As we previously reported on this blog, the medical devices have been linked to at least 20 deaths. The concerns involve leads that connect an implantable cardioverter defibrillator (ICD) to the heart in [...] Read more »
Could the “Weekend Effect” Put You at Risk for a Serious Medical Error?
by vaagelaw August 16, 2012 » Add the first comment.
As San Diego medical malpractice attorneys, we are concerned that yet another study has confirmed the existence of the “weekend effect.” Researchers at Johns Hopkins University found that older adults who sustain substantial head trauma over a weekend are significantly more likely to die from their injuries than those similarly hurt and hospitalized on weekdays. [...] Read more »
San Diego Product Liability Attorney Explains Medical Device Recalls
by vaagelaw July 5, 2012 » Add the first comment.
Medical device recalls are conducted to address a problem with a medical device that violates safety regulations enforced by the U.S. Food and Drug Administration. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. In most cases, [...] Read more »
