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
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medical device
Supreme Court Declines to Review Medical Device Case
By Sean Wajert on
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 …
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Class Certification Denied Under Ascertainability Analysis
By Sean Wajert on
We typically focus on appellate decisions regarding class certification, but wanted to note for you a recent lower court federal decision in case invo…
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Bill Introduced to Amend Post-Market Review of Medical Devices
By Sean Wajert on
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…
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Strict Liability Does Not Apply to Medical Devices
By Sean Wajert on
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…
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IOM Releases Controversial 510K Device Report
By Sean Wajert on
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…
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State Supreme Court Upholds Verdict For Device Maker
By Sean Wajert on
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…
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Third Circuit Rejects Medical Monitoring in Device Case
By Sean Wajert on
The Third Circuit has properly recognized that a claim for medical monitoring claim does not lie against the manufacturer of a medical device product.…
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Federal Court Dismisses Device “Consumer” Claims
By Sean Wajert on
A federal court last month dimissed claims by plaintiffs concerning hip implants, with an analysis important for other consumer protection-type class …
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IOM To Study 510(k) Process for Medical Devices
By Sean Wajert on
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 …
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