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HTMLRecord Setting Verdict of $73 Million in Mesh Case
Katie Nealon; Brayton Purcell LLP;
Legal Alert/Article
October 19, 2014, previously published on September 18, 2014
Boston Scientific, a Massachusetts-based medical device company, was ordered to pay $73 million after a jury found that it was liable for leaving a woman in severe pain following a vaginal mesh implant. The award was comprised of $23 million in compensatory damages and $50 million in punitive...

 

HTMLThe Dilemma of the Unintended Fiduciary
Edward M. McNally; Morris James LLP;
Legal Alert/Article
October 19, 2014, previously published on October 8, 2014
A recent Delaware decision highlights a trap for the unwary adviser to a business entity. The decision holds that helping a business get started may create fiduciary duties owed by the adviser, even if he or she is not acting in one of the roles that are normally thought of as creating such duties,...

 

HTMLFDA Releases Framework for Overseeing Laboratory Developed Tests
Laurie A. Clarke, Brigid C. DeCoursey, Colleen Heisey; Jones Day;
Legal Alert/Article
October 16, 2014, previously published on October 2014
On September 30, 2014, the U.S. Food and Drug Administration ("FDA") released the two draft guidance documents setting forth FDA's proposed framework for regulating Laboratory Developed Tests ("LDTs") as medical devices: (i) Draft Guidance for Industry, Food and Drug...

 

HTMLFederal Circuit Jurisdiction Over Patent Contract Disputes
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 15, 2014, previously published on October 9, 2014
In a precedential order issued in Jang v. Boston Scientific Corp., the Federal Circuit held that it has jurisdiction over the parties’ patent-related contract dispute under Gunn v. Minton even though the patents at issue have been invalidated. Despite having found Federal Circuit...

 

HTMLFederal Circuit Hears Arguments in Other Myriad Gene Patents Case
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 13, 2014, previously published on October 7, 2014
On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the district court’s denial of Myriad’s motion for a preliminary...

 

HTMLPelvic Mesh Trial News: Juries Award Significant Damages
Wendy R. Fleishman; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
October 8, 2014, previously published on September 23, 2014
Thousands of injured women nationwide have filed lawsuits in state and federal courts against manufacturers of surgical pelvic mesh implants, claiming that the design of the product was defective and led to serious side effects and permanent injuries. These serious health complications include...

 

Adobe PDFPTAB Provides Guidance for Meeting Burden to Show Written Description for Substitute Claim
John P. Iwanicki; Banner & Witcoff, Ltd.;
Legal Alert/Article
October 7, 2014, previously published on September 24, 2014
In a Final Written Decision finding the patentee’s claim 1 unpatentable, the PTAB denied a motion to add a substitute claim that added hundreds of words to challenged claim 1. The PTAB held that the patentee failed to explain the relevance of supporting citations to the patent, or how the...

 

HTMLNobel Biocare Files New 337 Complaint Regarding Certain Dental Implants
Alexander B. Englehart, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
October 6, 2014, previously published on September 29, 2014
On September 25, 2014, Nobel Biocare Services AG of Switzerland and Nobel Biocare USA, LLC of Yorba Linda, California (collectively, "Nobel") filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

 

HTMLTwo Fishy Recalls Issued
Jennifer L. Keel; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
October 1, 2014, previously published on September 26, 2014
Gold Star Smoke Fish Corp. is recalling its Cold Smoked Steelhead in vaccuum packs, featuring blue and gold labels, over fear the meat could have become contaminated by Listeria monocytogenes.

 

HTMLClass I Recall For Post-Surgical Jaw Stabilizer
Jennifer L. Keel; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
September 30, 2014, previously published on September 26, 2014
The U.S. Food and Drug Administration has recently issued a safety alert for the DePuy Synthes Craniomaxillofacial (CMF) Distraction System, which includes AB Distractor Bodies and BC Distractor Bodies. The device, also referred to as an external mandibular fixator, a distractor or a bone plate, is...

 


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