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Published by Sean P. Wajert

Mass Tort Defense

Defense of Mass Tort Claims, Class Actions, and Significant Product-Based Litigation

medical device

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Abandonment Issues in an MDL

By Sean Wajert on October 21, 2015
Posted in Articles, Drug and Device

The defendant in a medical device MDL recently flagged an important and thorny issue that impacts many if not most MDL’s. And it has to do with bellwe…
Continue Reading Abandonment Issues in an MDL

Supreme Court Declines to Review Medical Device Case

By Sean Wajert on October 2, 2012
Posted in Articles, Drug and Device

Earlier this week, the Supreme Court declined to hear plaintiff’s challenge to the Fourth Circuit’s decision on an important aspect of medical device …
Continue Reading Supreme Court Declines to Review Medical Device Case

Class Certification Denied Under Ascertainability Analysis

By Sean Wajert on July 6, 2012
Posted in Articles, Class Action, Drug and Device

We typically focus on appellate decisions regarding class certification, but wanted to note for you a recent lower court federal decision in case invo…
Continue Reading Class Certification Denied Under Ascertainability Analysis

Bill Introduced to Amend Post-Market Review of Medical Devices

By Sean Wajert on December 22, 2011
Posted in Articles, Drug and Device

Three U.S. Senators recently introduced legislation that would alter the U.S. Food and Drug Administration’s post-market surveillance of medical devic…
Continue Reading Bill Introduced to Amend Post-Market Review of Medical Devices

Strict Liability Does Not Apply to Medical Devices

By Sean Wajert on November 26, 2011
Posted in Articles, Drug and Device

Another court has recognized that strict liability or breach of implied warranty claims do not lie against medical device makers. Horsmon v. Zimmer Ho…
Continue Reading Strict Liability Does Not Apply to Medical Devices

IOM Releases Controversial 510K Device Report

By Sean Wajert on July 29, 2011
Posted in Articles, Drug and Device

Earlier this week, an Institute of Medicine’s Committee released its report on the Public Health Effectiveness of the FDA 510(k) Clearance Proce…
Continue Reading IOM Releases Controversial 510K Device Report

State Supreme Court Upholds Verdict For Device Maker

By Sean Wajert on September 29, 2010
Posted in Articles, Drug and Device

The Connecticut Supreme Court recently took a second look at a case offering guidance on the application of the learned intermediary defense, and affi…
Continue Reading State Supreme Court Upholds Verdict For Device Maker

Third Circuit Rejects Medical Monitoring in Device Case

By Sean Wajert on September 8, 2010
Posted in Articles, Class Action, Drug and Device, Medical Monitoring

The Third Circuit has properly recognized that a claim for medical monitoring claim does not lie against the manufacturer of a medical device product.
Continue Reading Third Circuit Rejects Medical Monitoring in Device Case

Federal Court Dismisses Device “Consumer” Claims

By Sean Wajert on April 6, 2010
Posted in Articles, Class Action, Consumer Fraud, Consumer Products, Drug and Device

A federal court last month dimissed claims by plaintiffs concerning hip implants, with an analysis important for other consumer protection-type class …
Continue Reading Federal Court Dismisses Device “Consumer” Claims

IOM To Study 510(k) Process for Medical Devices

By Sean Wajert on September 30, 2009
Posted in Articles, Drug and Device

The U.S. Food and Drug Administration announced recently that it had commissioned the Institute of Medicine (IOM) to study the premarket notification …
Continue Reading IOM To Study 510(k) Process for Medical Devices

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Fax: 215.278.2594
Email: swajert@shb.com
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Mass Tort Defense Lawyer & Attorney Sean P. Wajert of Shook, Hardy & Bacon LLP, offering services relating to mass torts, product liability, class actions, medical monitoring, pharmaceutical litigation, consumer fraud act defense, complex litigation.

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