Medical Devices

Medtronic Agrees to Stop Manufacturing Defective Pain Pump
Medtronic Agrees to Stop Manufacturing Defective Pain Pump

Medtronic Corporation has agreed to stop manufacturing, designing, and distributing its SynchroMed II pump systems. The agreement resolves charges filed by the Department of Justice alleging that the medical device maker failed to address quality and safety concerns. The SynchroMed II implantable infusion pump system is...

Children's Tylenol Recall Results in $25 Million Fine
Children’s Tylenol Recall Results in $25 Million Fine

McNeil-PPC Inc., a subsidiary of Johnson & Johnson, will pay a $25 million penalty in connection with the 2010 recall of Infant's and Children's Tylenol and Motrin. The drug maker faced criminal charges for failing to promptly investigate consumer complaints that the medications were tainted...

World Health Organization Calls for Clinical Trial Transparency
World Health Organization Calls for Clinical Trial Transparency

The World Health Organization (WHO) is calling for greater transparency in medical research, particularly with regard to disclosing the results from clinical trials for medical products. As San Diego injury lawyers, we agree that failing to report the results of pharmaceutical and medical device research...

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...