In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest new data and adjust accordingly – a feature that…
Blog Archives
How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for Artificial Intelligence/Machine Learning-Based Medical Devices
Posted in FDA
ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims
The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question presented on appeal is “whether…
Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices
The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are devices which contain differently classified…
State Court Relies Upon Supreme Court’s Bristol-Meyers Squibb Decision to Vacate Jury Verdict Against J&J
The Supreme Court limited a striking vulnerability for product manufacturers in Bristol-Myers Squibb Co. v. Superior Court of California this summer when it ruled that out-of-state plaintiffs could not simply claim injuries that were similar to residents to support specific…
Supreme Court Solidifies Specific Jurisdiction Analysis To Dismiss Product Claims Filed Against Non-Resident Defendant, Bristol-Myers Squibb Co.
Product manufacturers routinely hauled into court in far away, inconvenient jurisdictions can breathe a little easier with the Supreme Court’s decision this week in Bristol-Myers Squibb Co. v. Superior Court of California. A group of plaintiffs, most of whom were…
SCOTUS Decisions May Provide A Roadmap to Enforcing Arbitration Clauses Included In Product Packaging
It is open opinion season at the U.S. Supreme Court, and two recent decisions pertaining to the enforceability of arbitration clauses provide guidance to manufacturers looking to bind consumers through the use of product packaging. In Kindred Nursing Centers Limited…
Lack of Specificity May Kill Parallel State Law Product Claims, But Not Fraud Claim
A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the manufacturer, Medtronic, Inc., to proceed at the…
FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels
The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”. The draft guidance is intended to assist…
Posted in FDA
New Weapon For Manufacturers: Defend Trade Secrets Act of 2016
On May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic Espionage Act. While the…
Posted in Manufacturer, Trade Secrets
U.S. DOT Moving Closer to Certification of Driverless Cars
Motor vehicle design continues to make significant technological leaps incorporating a number of automated features, with many manufacturers pioneering the concept of driverless cars. What was once the stuff of science fiction is making significant headway towards full-scale production and…
Posted in Automotive
