It is spring time — although you might not know it from the weather — and it is time for one of the premier educational and networking conferences f
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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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Defense Equal Access to Potential Experts Upheld in Device Case
By Sean Wajert on
Posted in Articles, Drug and Device
A Joe Friday post today- just the facts with no commentary. A state appellate court earlier this month overturned a trial court order that had limited…
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House Passes FDA Reauthorization Bill
By Sean Wajert on
Posted in Articles, Drug and Device
The House of Representatives last week passed a bill (387 to 5 vote) that would reauthorize the Food and Drug Administration’s user fee programs and a…
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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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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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Upcoming Drug and Medical Device Seminar
By Sean Wajert on
Posted in Articles, Drug and Device
DRI’s Drug and Medical Device Committee will hold its 26th annual Seminar on May 20-21, 2010, at the San Francisco Marriott, in San Francisco, C…
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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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Appeals Court Upholds Summary Judgment on Negligence Per Se Claim
By Sean Wajert on
Posted in Articles, Drug and Device
Last week, the Ninth Circuit upheld summary judgment for the maker of an artificial disc on a claim that the company’s alleged off-label promotion of …
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