Medical Devices

Medical device labeling
FDA to Study Medical Device Labeling

While labels on prescription medications must follow a standard format, the same requirements do not apply to medical devices. As a result, doctors and patients may not always be aware of important safety information. Under existing federal law, medical device manufacturers are required to include certain...

Proposed guidance from the U.S. Food and Drug Administration (FDA) is receiving significant criticism from patient safety advocates.
FDA Proposal About Drug Marketing Puts Patients at Risk

Proposed guidance from the U.S. Food and Drug Administration (FDA) is receiving significant criticism from patient safety advocates. It would allow pharmaceutical companies to inform doctors that the prescription labels approved by the FDA overstate a medication’s risks by distributing peer-reviewed articles and by having...

The U.S. Food and Drug Administration (FDA) recently announced new guidelines for the reprocessing of reusable medical devices.
Will New Guidance Curb the Spread of Infection Via Reusable Medical Devices?

The U.S. Food and Drug Administration (FDA) recently announced new guidelines for the reprocessing of reusable medical devices. According to the agency, the actions are intended to “enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.” 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...

Courtroom-Gavel
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...