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Documents on products liability
 

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HTMLFDA to Undergo Changes As Recommendations for Re-Alignment are Released Amid "Unparalleled Challenges" Posed By Product Complexity and Globalization
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
More 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.

 

HTMLFDA 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;
Legal Alert/Article
January 23, 2015, previously published on October 2014
In 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.

 

HTMLFDA 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;
Legal Alert/Article
January 23, 2015, previously published on October 2014
As 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.

 

HTMLFda 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;
Legal Alert/Article
January 23, 2015, previously published on October 2014
The 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.

 

HTMLVerdict For Automotive Manufacturer Reversed Where Trial Judge Erred In Admitting Entire NHTSA Report
Sutherland Asbill Brennan LLP;
Legal Alert/Article
January 15, 2015, previously published on December 11, 2014
On 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...

 

HTMLFTC Takes Action Against Unsubstantiated Caffeine-Infused Shapewear Weight-Loss Claims
Sheppard Mullin Richter Hampton LLP;
Legal Alert/Article
January 13, 2015, previously published on October 24, 2014
Wacoal 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...

 

Adobe PDFThe New Product Liability Paradigm in Pennsylvania
Keith E. Whitson; Schnader Harrison Segal & Lewis LLP;
Legal Alert/Article
January 12, 2015, previously published on November 2014
The 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...

 

HTMLALJ 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.;
Legal Alert/Article
January 10, 2015, previously published on December 15, 2014
On 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.

 

Adobe PDFChanges 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;
White Paper
January 8, 2015, previously published on December 1, 2014
On 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...

 

HTMLPennsylvania 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;
Legal Alert/Article
December 26, 2014, previously published by Burns White website
The 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...

 


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