Readers of MassTortDefense interested in the issues surrounding medical monitoring will want to keep their eyes on Hess v. A.I. DuPont Hosp. For Child
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medical device
Senate Holds Hearing On Medical Device Safety Bill
By Sean Wajert on
Posted in Articles, Drug and Device
The Senate Health, Education, Labor, and Pensions Committee last week held a hearing on the Medical Device Safety Act of 2009 (S. 540), which if enact…
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FDA Issues New Draft Guidance on Presenting Risk Information
By Sean Wajert on
Posted in Articles, Drug and Device
The FDA recently issued a new draft Guidance for Industry titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.
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Administration Releases Memorandum On Preemption
By Sean Wajert on
Posted in Articles, Drug and Device
The Democratic assault on the preemption doctrine has taken its next step with the release last week by the White House of a Presidential memorandum w…
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Members of Congress to Re-introduce Medical Device “Safety” Bill
By Sean Wajert on
Posted in Articles, Drug and Device
Democratic members of Congress are planning to re-introduce legislation that would overturn the February, 2008 Supreme Court decision in Reigel v. Med…
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Federal Court Predicts Delaware Would Recognize Medical Monitoring In Device Context- But Why?
By Sean Wajert on
Two recent, related federal court opinions illustrate just how unsettled the law of medical monitoring continues to be. Molly Guinan V. A.I. Dupont Ho…
Continue Reading Federal Court Predicts Delaware Would Recognize Medical Monitoring In Device Context- But Why?
Daubert Lessons From Two Medical Device Cases
By Sean Wajert on
Posted in Articles, Drug and Device
Two recent federal cases illustrate important Daubert principles in the medical device context. In Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill.,…
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FDA Issues Guidance On Distribution Of Medical And Scientific Articles Regarding Off-Label Usage
By Sean Wajert on
Posted in Articles, Drug and Device
The FDA has finalized guidelines for how manufacturers can distribute information to doctors about unapproved uses for drugs or medical devices. The &…
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White Paper On Combination Products
By Sean Wajert on
Posted in Articles, Drug and Device
Dr. Steven Richter has issued a white paper, “Combination Products: Navigating Two FDA Quality Systems.” Dr. Richter founded the consultin…
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PMA Device Preemption Recognized Despite “Parallel” Allegation
By Sean Wajert on
Posted in Articles, Drug and Device
Those readers defending PMA medical device defendants should review Parker v. Stryker Corp., 2008 WL 4716879 (D. Colo. Oct. 22, 2008); the district co…
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