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Documents on products liability
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|FDA to Undergo Changes As Recommendations for Re-Alignment are Released Amid "Unparalleled Challenges" Posed By Product Complexity and Globalization|
Loeb Loeb LLP;
January 23, 2015, previously published on October 2014More than a year after its creation, the Program Alignment Group (PAG) issued final recommendations on how to realign the FDA, releasing six distinct "Action Plans" in a bid to improve the agency’s structure and regulation.
|FDA Puts Final Touches on Inspection Guidance to Provide More Clarity and Respond to Industry Concerns, While Maintaining Strong Stance on Its Photography Authority|
Loeb Loeb LLP;
January 23, 2015, previously published on October 2014In finalizing a policy aimed at ensuring companies aren’t able to hide problems during inspections, the agency provided the industry with additional details regarding facility inspections in a bid to reduce confusion, adding descriptive material and preserving robust rules about photography.
|FDA Attempts to Increase Security of Mobile Devices in Midst of Growing Threat of Cyberattacks with Guidance Focusing on Security-By-Design, While Some Say Focus Should Be on Data|
Loeb Loeb LLP;
January 23, 2015, previously published on October 2014As the regulator attempts to play catch-up with the fast-evolving world of connected devices by issuing guidance, critics fear the regulations fail to fully address the complexity of cyber threats.
|Fda Issues Final Guidance on Discerning Device Recalls from Market Withdrawals Related to Medical Device Enhancements in Apparent Bid to Appease Industry Concern Over Draft Being Overly Broad, Lacking in Term Definitions|
Loeb Loeb LLP;
January 23, 2015, previously published on October 2014The regulator put out the final guidance document to ensure companies are able to clearly distinguish a recall from a market withdrawal after the draft version sparked concern and confusion throughout the industry.
|Verdict For Automotive Manufacturer Reversed Where Trial Judge Erred In Admitting Entire NHTSA Report|
Sutherland Asbill Brennan LLP;
January 15, 2015, previously published on December 11, 2014On Wednesday, the Court of Appeals of Missouri reversed a jury verdict in favor of an automotive manufacturer and remanded the case for a new trial. In 2003, a Missouri state trooper was killed and a passenger in his car was severely injured when a truck driver veered onto the shoulder of the...
|FTC Takes Action Against Unsubstantiated Caffeine-Infused Shapewear Weight-Loss Claims|
Sheppard Mullin Richter Hampton LLP;
January 13, 2015, previously published on October 24, 2014Wacoal America and Norm Thompson, both manufacturers of women’s shapewear, recently entered into consent orders to pay sums of $230,000 and $1.3 million, respectively, and agree to not make any false and misleading future claims that their products cause weight loss, fat loss or eliminate...
|The New Product Liability Paradigm in Pennsylvania|
Keith E. Whitson; Schnader Harrison Segal & Lewis LLP;
January 12, 2015, previously published on November 2014The Pennsylvania Supreme Court this past week dramatically altered the landscape of product liability litigation in Pennsylvania. In Tincher v. Omega Flex, Inc., No. 17 MAP 2013 (Pa. November 19, 2014), the Court overruled long-standing precedent that stringently segregated negligence concepts from...
|ALJ Pender Consolidates 337-TA-928 and 337-TA-937 Investigations Regarding Certain Windshield Wipers|
Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
January 10, 2015, previously published on December 15, 2014On December 9, 2014, ALJ Thomas B. Pender issued Orders consolidating Inv. Nos. 337-TA-928 and 337-TA-937 relating to Certain Windshield Wipers and Components Thereof. Please note that Oblon Spivak represents Complainants in both of these matters.
|Changes in Products Liability Law: The PA Supreme Court Overturns 35 Years of Products Liability Law: The New Products Liability Cause of Action is a “Judicially Created Hybrid: ‘A Wart’”|
Christopher S. Channel; Leech Tishman;
January 8, 2015, previously published on December 1, 2014On November 19, 2014, the Pennsylvania Supreme Court issued a long-awaited decision that alters the strict products liability landscape in Pennsylvania. In Tincher v. Omega Flex, Inc., Chief Justice Castille authored an 137-page opinion in which Justices Bear, Todd and Stevens joined, while Justice...
|Pennsylvania Remains a Second Restatement Jurisdiction: The Impact of the Pennsylvania Supreme Court's Decision in Tincher v. Omega Flex, Inc.|
Nichole E. Humes, Stephanie Solomon; Burns White LLC;
December 26, 2014, previously published by Burns White websiteThe Pennsylvania Supreme Court has politely declined an invitation to adopt the Restatement (Third) of Torts: Products Liability §§ 1 et seq., opting instead to “appreciate certain principles” contained in that Restatement in a new standard of proof which allows a plaintiff...