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Medical Devices › Warning Labels

Foley Hoag LLP

Product Liability Update - April 2023

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MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more

Butler Snow LLP

Trust the reProcess? A Practical and Legal Overview of Reprocessing Single-Use Medical Devices in the United States

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Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the tissue and cartilage in his...more

Harris Beach PLLC

FDA Proposes Strengthening Warning Labels on Breast Implants

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The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

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Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Dorsey & Whitney LLP

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part II – Medical Product Communications that are Consistent...

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On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product...more

Foley Hoag LLP

Product Liability Update: October 2017

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Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Akin Gump Strauss Hauer & Feld LLP

Under What Circumstances Can a Private Qui Tam Plaintiff Overrule Government Agency Experts' Use of Administrative Discretion to...

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• How have appellate courts applied the Supreme Court’s ruling in Escobar? • If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

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The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Knobbe Martens

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

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Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Nutter McClennen & Fish LLP

Product Liability: 2015 Year in Review

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Massachusetts state and federal courts issued a number of important product liability decisions in 2015. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

Knobbe Martens

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

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The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more

Stoel Rives LLP

Prop 65 Law Alert: California Proposes Significant Changes to Proposition 65 Warning Requirements

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On March 7, 2014, the Office of Environmental Health Hazard Assessment (“OEHHA”), the agency responsible for implementing California’s Proposition 65 (“Prop 65”), issued proposed changes to existing regulations that would...more

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