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HTMLBaxter Files New 337 Complaint Regarding Certain Hemostatic Products
Alexander B. Englehart, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
March 7, 2014, previously published on March 5, 2014
On February 28, 2014, Baxter International Inc. of Deerfield, Illinois, Baxter Healthcare Corp. of Deerfield, Illinois, and Baxter Healthcare SA of Switzerland (collectively, “Baxter”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.


HTMLReflecting on the First Year of CDRH’s 510(k) Refuse to Accept Policy
Jeffrey N. Gibbs, Allyson Mullen; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
February 27, 2014, previously published on February 26, 2014
The end of 2013 marked the first anniversary of CDRH’s Refuse to Accept Policy for 510(k)s (the “RTA”). FDA, Guidance for Industry and FDA Staff, Refuse to Accept Policy for 510(k)s (December 2012). Therefore, we thought it would be a good time to reflect on how well the RTA has...


HTMLTakeda Prevacid SoluTab Patent Valid, But Not Infringed
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
February 27, 2014, previously published on February 24, 2014
In Takeda Pharmaceutical Company Ltd. v. Zydus Pharmaceuticals USA, Inc., the Federal Circuit reversed the district court’s finding that Zydus’s proposed generic product infringed Takeda’s Prevacid® SoluTab™ patent, but agreed with the district court that Zydus had...


HTMLBiomet Hip Implant Settlement Surpasses $56 Million
Katie Nealon; Brayton Purcell LLP;
Legal Alert/Article
February 25, 2014, previously published on February 21, 2014
Metal-on-metal hip implants were once praised as the latest advancement in joint replacement, but since their introduction into the medical world, they have caused more harm than good. We have previously reported on Johnson & Johnson's DePuy settlement that reached $4 billion and affected over...


HTMLFDA Issues Final Rule and Guidance on Electronic MDR Reporting
Allyson B. Mullen; Hyman Phelps McNamara P.C.;
Legal Alert/Article
February 24, 2014, previously published on February 19, 2014
On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). The Final Rule does not materially...


HTMLFDA Memorandum Outlines Significant Overhaul of Inspection and Compliance Processes
Jonathan Berman, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
February 24, 2014, previously published on February 2014
In an internal memorandum to FDA leadership, Commissioner Margaret Hamburg "chart[s] the course for modifying Agency functions and processes to improve communication and collaboration and to clarify roles and responsibilities and decision rights across all Agency components."


HTMLConsiderations If Conceding Infringement Or Designing Around
Rebecca J. Pirozzolo-Mellowes; Foley & Lardner LLP;
Legal Alert/Article
February 19, 2014, previously published on February 18, 2014
A decision issued by the Federal Circuit earlier this year raises a few things to have in mind when considering whether to concede infringement and when planning to design around a patent.


HTMLStem Cells Grown in Lab Prior to Clinical Use as Transplantation Product Are Biological Drugs Subject to FDA Rules
Colleen K. O'Brien; Semmes, Bowen & Semmes A Professional Corporation;
Legal Alert/Article
February 18, 2014, previously published on February 2014
In this civil enforcement action, the U.S. Court of Appeals for the District of Columbia Circuit decided whether Defendants, Regenerative Sciences and three (3) individuals (collectively Regenerative Sciences), violated the Federal Food, Drug & Cosmetic Act (FDCA), 21 U.S.C. § 301, et...


HTMLW.Va. Doesn't Understand The Scientific Method: Part 1
David A. Oliver; Vorys, Sater, Seymour and Pease LLP;
Legal Alert/Article
February 17, 2014, previously published on February 13, 2014
Milward v. Acuity has spawned another troubling anti-science opinion: Harris v. CSX Transportation Inc.Whereas Milward held that credentialed wise men should be allowed to testify that an effect that has never been observed (indeed one that could not be detected by any analytical method known to...


HTMLFDA Releases Final eMDR Rule and Deadline for Compliance
Joseph Hammang, Daniel J. Herling; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
February 17, 2014, previously published on February 13, 2014
The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a deadline for compliance has been identified. The rule impacts device manufacturers and importers and...


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