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HTMLPublic Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA's Hackles if They Do Not Meet Basic Requirements for Promotional Communications
Joanne S. Hawana; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 26, 2015, previously published on June 23, 2015
For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s...

 

HTMLWritten Reasons in Administrative Decisions
Field Law;
Legal Alert/Article
June 26, 2015, previously published on June 9, 2015
Fashoranti v. College of Physicians and Surgeons of Nova Scotia, 2015 NSCA 25, dismissing an appeal from the disciplinary committee’s finding that a physician committed unprofessional conduct.

 

HTMLF.B.I. Investigates Power Morcellator Injuries
Waters Kraus LLP;
Legal Alert/Article
June 25, 2015, previously published on June 22, 2015
June 22, 2015 - The Federal Bureau of Investigation (F.B.I.) reportedly has launched an investigation into whether laws were broken by medical device manufacturers of the power morcellator device. Used in gynecologic surgery to perform hysterectomies and remove fibroid tumors, the power morcellator...

 

HTMLFDA Determines Artificial Trans Fat Are No Longer “Generally Recognized as Safe”; Must Be Removed From Human Food By June 2018
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 24, 2015, previously published on June 19, 2015
Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over the next three years. PHOs in ready-to-eat foods like baked goods, snack...

 

HTMLFlorida's Daubert Jurisprudence Gradually Continues to Evolve: First District Decision Emphasizes Timeliness of Daubert Motions & Other Nuances
Armando G. Hernandez; Rumberger, Kirk & Caldwell Professional Association;
Legal Alert/Article
June 24, 2015, previously published on June 18, 2015
On May 29, 2015, Florida’s First District Court of Appeal issued a per curiam opinion thoroughly examining the seemingly new Daubert test as a matter of Florida law. See Booker v. Sumter Cnty. Sheriff's Office/N. Am. Risk Servs., No. 1D14-4812, 2015 WL 3444359 (Fla. 1st DCA May 29, 2015). The...

 

HTMLFDA Finds that Artificial Trans Fats Are Unsafe
Edgar J. Asebey, Jonathan Berman, Colleen Heisey, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
June 24, 2015, previously published on June 2015
On June 16, 2015, FDA announced it has finalized its determination that partially hydrogenated oils ("PHOs") are not "generally recognized as safe" ("GRAS") for use in human food. This finding effectively bans PHOs, which are the primary source of artificial trans fat...

 

HTMLCPSC Files Suit for Second Time in Three Months against a Company for Alleged Failure to Timely Report Defective Product
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 24, 2015, previously published on June 22, 2015
On Wednesday of last week, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) announced that a complaint has been filed in federal court against Spectrum Brands, Inc. (Spectrum). Notably, this is the second case in the past three months brought by the government in...

 

HTMLObjecting to Expert Evidence Based on Novel Science
Steve M. Vorbrodt; Singleton Urquhart LLP;
Legal Alert/Article
June 23, 2015, previously published on June 19, 2015
In product liability and other personal injury cases, the courts will sometimes be asked to consider expert evidence based on theories that deviate from accepted standards in the scientific community. The polite term for such theories is “novel” science while the more informal term is...

 

HTMLGMOs at the Ballot Box: the Drama Continues
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 18, 2015, previously published on May 28, 2015
Joining the rising tide of local GMO legislation, last week voters in Benton County, Oregon defeated the Benton County Local Food System Ordinance, which would have prohibited the cultivation of GMO crops in the county. The proposed legislation follows on the heels of a Jackson County, Oregon GMO...

 

HTMLBig Win for Anti-GMO Groups as Federal Judge Upholds Jackson County GMO Ban
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 18, 2015, previously published on June 2, 2015
On Friday, Federal Magistrate Judge Mark D. Clarke partially dismissed a lawsuit brought by commercial alfalfa farmers seeking to overturn a Jackson County ordinance that banned the use of GMO seed stock (“It is a county violation for any person or entity to propagate, cultivate, raise, or...

 


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