Medical Devices

FDA Strengthening Oversight Over Defibrillators
FDA Strengthening Oversight Over Defibrillators

Automated external defibrillators (AEDs) can save lives. However, they don’t always work when you need them. From January 2005 through September 2014, the U.S. Food and Drug Administration received approximately 72,000 reports of device failure. Over the same time period, manufacturers have conducted 111 recalls involving...

IV Solution from San Diego Company Sickened Patients
IV Solution from San Diego Company Sickened Patients

As San Diego product liability lawyers, we are extremely concerned by reports that an intravenous solution made by a San Diego company has sickened 17 patients and potentially killed one. According to the U.S. Food and Drug Administration (FDA), the IV solution is intended for...

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Are Hospitals Downplaying the Risks of Heart Valve Replacement?

A new study suggests that hospitals are touting the benefits of a common heart valve replacement procedure without fully explaining the risks. The findings should remind patients that hospital websites are often more like advertisements than educational resources.   As Reuters reports, the procedure, known as a...

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FDA Issues Warning Over Medical Device’s Risk of Spreading Cancer

The U.S. Food and Drug Administration (FDA) recently strengthened its warning against the use of laparoscopic power morcellators to treat uterine fibroids. The agency is recommending that the procedure not be performed in most women because it can unwittingly spread cancer. During surgery to remove the...

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Boston Scientific Loses Two Jury Trials Over Faulty Vaginal Mesh Devices

Boston Scientific Corp. recently lost two high-profile product liability lawsuits involving its vaginal mesh devices. The cases are among the first of more than 14,000 suits pending across the country to go to trial. In West Virginia, a federal jury awarded a total of $18.5 million...

Preventing Medical Errors Caused By Miscommunication

Miscommunication plays a role in approximately 80 percent of the most serious medical errors that occur in U.S. hospitals, such as delays in diagnosis, preventable surgical complications, and medication overdoses. Many of the mistakes occur when patients are handed off from one healthcare provider to...

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New Study Confirms Robotic Surgery Fails to Live Up to the Hype

Hospitals, doctors, and device makers frequently tout the benefits of robotic surgery. However, a new study highlights that it may be more costly and lead to more complications when compared to traditional, low-tech methods. The number of robotic surgeries has skyrocketed in recent years, accounting for...

FDA Seeking to Shut Down Medical Device Company Over Patient Infections

Federal regulators are working to shut down a medical device company that produced ultrasound, mammography, and electrocardiogram gels that have been tied to at least 16 infections. Working with the Department of Justice, the U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Pharmaceutical...

Jury Awards $73 Million in Transvaginal Mesh Suit

A Texas jury recently awarded $73 million in damages in a lawsuit against Boston Scientific involving a transvaginal mesh device. The jury verdict included $50 million in punitive damages after finding the company was grossly negligent in the design and marketing of its Obtryx sling. According...

Health
How Many Medical Errors Occur at California Hospitals?

In California, hospitals are required to report medical errors to the state Department of Public Health. However, the information is not easily accessible to the public. To determine how prevalent medical mistakes are in California hospitals, NBC Bay Area filed a public records request to gain...