Category Archives: Products Liability

Supreme Court Says Government Can ‘Indefinitely’ Detain Some Legal Immigrants

A narrow win for the Trump administration, the ruling lets federal officials deport immigrants who've served criminal sentences in the distant past... To continue reading this legal news please click Read full information...

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West Virginia Sues Catholic Bishop and Diocese for Hiring Priests with Child Sex Abuse Backgrounds

A.G. Morrissey claims that, in some cases, the Church sent suspected molesters to rehab and then rehired them... To continue reading this legal news please click Read full information...

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“Bare-Metal” Defense Treading Water Under Maritime Law

Danielle T. Gauer and Tye C. Bell In a 6-3 ruling on March 19, 2019, the United States Supreme Court held that, under maritime law, a product manufacturer has a duty to warn when its “bare metal” product requires incorporation of a part the manufacturer knows or has reason to know is likely to be dangerous, such as asbestos-containing components. In Air & Liquid Systems Corp., et al. v. DeVries, No. 17-1104, 586 U.S. ___ (2019), the Supreme Court examined the scope of a manufacturer’s duty to warn of the dangers of asbestos when its own bare metal products are later combined with asbestos-containing parts that the manufacturer did not make or sell. Plaintiffs Kenneth McAfee and John DeVries (“Plaintiffs”) filed suit in state court against a number of product manufacturers alleging that they developed cancer as a result of exposure to asbestos-containing equipment, including pumps, blowers, and turbines manufactured by the defendants, while….. To continue reading this legal news please click Read full information...

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A Doggone Shame for Vanda: DC District Court Grants FDA’s Remand Motion on Dog Study/IND Clinical Hold Challenge

By Sara W. Koblitz — About 6 weeks after Vanda filed its complaint, the company’s lawsuit has joined its clinical trial: on hold.  Last week, the District Court of D.C. granted FDA’s motion for a voluntary remand of the case challenging FDA’s requirement to perform 9-month large animal studies prior to commencing studies in humans staying the case for 45 days from the Court’s Order while FDA reevaluates its position.  While Vanda supported a voluntary remand, it strongly advocated that the Court stay the case while vacating the clinical hold on its 52-week human study. FDA requested a voluntary remand to “address certain procedural issues Vanda noted in its Complaint, including the allegations about the agency’s response to scientific arguments submitted by Vanda and the treatment of a guidance document as a binding rule.”  Notwithstanding all the usual pre-litigation negotiations about the issue that were discussed….. To continue reading this legal news please click Read full information...

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To Ask, or Not to Ask, That is the Question: FDA Guidance on Nonbinding Feedback After Certain Inspections of Device Establishments

By Rachael E. Hunt — FDA recently issued a draft guidance document, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection. Background Section 702 of the FDA Reauthorization Act of 2017 (FDARA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require FDA to provide nonbinding feedback in certain circumstances after an FDA inspection of a device establishment.  Specifically, FDCA section 704(h)(2) states: (A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request. (B) A request described in this subparagraph is a request for feedback— (i) that is made by the owner, operator, or agent….. To continue reading this legal news please click Read full information...

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