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Manufacturers Food and Drug Administration (FDA) Manufacturing Defects

Epstein Becker & Green

Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program

At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more

Nutter McClennen & Fish LLP

Product Liability 2022 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

Kohn, Kohn & Colapinto LLP

Manufacturer of Defective Heart Devices Settles False Claims Act Case for $27 Million

St. Jude Medical Inc. (“St. Jude”), which was acquired by Abbott Laboratories in 2017, entered into a settlement last week with the United States Department of Justice (“DOJ”) for $27 million to resolve allegations it had...more

Faegre Drinker Biddle & Reath LLP

Indiana State and Federal Courts Rule That Manufacturing Defect Claims May Survive Preemption in PMA Context

Indiana courts have recently addressed preemption issues in matters involving devices approved by the Food and Drug Administration (FDA) through the premarket approval (PMA) process. First, the Indiana Court of Appeals...more

Hogan Lovells

CDRH's Voluntary Malfunction Summary Reporting Program

Hogan Lovells on

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...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

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