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Food and Drug Administration (FDA) › Failure To Warn › Manufacturing Defects

Searcy Denney Scarola Barnhart & Shipley

Defective Medical Devices and Their Impact on Patient Safety

Searcy Denney Scarola Barnhart & Shipley on

Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA): “Each year, the FDA receives over two million medical...more

Cozen O'Connor

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Cozen O'Connor on

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

Foley Hoag LLP

Product Liability Update - July 2015

Foley Hoag LLP on

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Searcy Denney Scarola Barnhart & Shipley

The Boston Mesh Litigation

Searcy Denney Scarola Barnhart & Shipley on

Mesh products have been regularly used to repair abdominal hernias since the 1950s. In the 1970s, gynecologists used surgical mesh products designed for abdominal hernia repair to repair prolapsed organs....more

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