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Documents on Antitrust & Trade Regulation, Pharmaceuticals, Health Care
 

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HTMLSupreme Court Of Canada Denies Leave To Appeal From Decision Clarifying Available Disgorgement Remedies In Competition And Consumer Protection Claims
Michelle T. Maniago, Alessandra V. Nosko; Borden Ladner Gervais LLP;
Legal Alert/Article
September 18, 2014, previously published on September 8, 2014
On Thursday, September 4, 2014, the Supreme Court of Canada dismissed the plaintiffs’ motion for leave to appeal in Wakelam v. Wyeth Consumer Healthcare/Wyeth Soin de Sante Inc. The leave application arose from a 2014 British Columbia Court of Appeal decision that clarified whether plaintiffs...

 

HTMLFDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 18, 2014, previously published on September 9, 2014
On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to generic drug development, and the FDA’s procedure for...

 

HTMLFTC Doubles Down in Challenge to Pharmaceutical Settlement
Paul M. Eckles, Karen Hoffman Lent, Sharis A. Pozen, Steven C. Sunshine; Skadden, Arps, Slate, Meagher & Flom LLP;
Legal Alert/Article
September 15, 2014, previously published on September 10, 2014
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging...

 

HTMLLiver Injury Cases Increased Along With Dietary and Herbal Supplement Sales
Seth A. Katz; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
September 11, 2014, previously published on September 5, 2014
A new study from researchers in Philadelphia revealed liver damage from dietary and herbal supplements might have increased over the last 10 years. The report "Liver injury from Herbals and Dietary Supplements in the U.S. Drug Induced Liver Injury Network" showed 4 percent of adult...

 

HTMLConsidering Sex-Specific Variation for Personalized Medicine
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
September 4, 2014, previously published on September 2, 2014
Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a particular cancer therapy. In some instances, the prediction of clinical...

 

HTMLBrand-Name Drug Manufacturer Liable For Personal Injuries Caused By Generic Drugs Manufactured By Different Company In Alabama
Sutherland Asbill Brennan LLP;
Legal Alert/Article
September 4, 2014, previously published on August 25, 2014
The Supreme Court of Alabama held last week that under Alabama law, a brand-name drug company can be held liable for fraud or misrepresentation based on statements made in connection with the manufacture of a brand-name prescription drug by a plaintiff claiming physical injury cause by a generic...

 

HTMLFDA Proposes a New Layer of Regulation for Laboratory Developed Tests
Caroline M. Tinsley; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
September 2, 2014, previously published on August 21, 2014
The Food and Drug Administration (FDA) announced its intention to expand the regulation of laboratory developed tests (LDTs). LDTs identify patients’ individual reactions to pharmaceutical treatments, so medical providers can prescribe the best treatment for the particular patient. Unlike...

 

HTMLGeneric Drug Labeling: Brand-Name Drug Manufacturers Can Be Held Liable for Warnings on Generic Versions
Fred Thompson; Motley Rice;
Legal Alert/Article
September 2, 2014, previously published on August 29, 2014
The controversial Wyeth v. Weeks decision, which was confirmed by the Alabama Supreme Court this past August 15, 2014, provided a welcome ray of hope in a preemption landscape made desolate by the Mensing decision of 2011.

 

HTMLBundled Discounts Subject to Section 1/Clayton 3 Scrutiny In the Absence of Market Power and Substantial Foreclosure?
Bruce A. Colbath; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 28, 2014, previously published on August 25, 2014
Bundled discount programs have received significant antitrust scrutiny over the past decade, even though these marketing programs may benefit both consumers and competition. Typically, bundled discounts have been evaluated as either exclusive dealing or tying arrangements under Section 1 of the...

 

HTMLSecond Circuit Clarifies the Use of Legal Presumptions of Consumer Confusion and Injury in Certain Lanham Act Cases
Bruce A. Colbath; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 27, 2014, previously published on August 21, 2014
On Tuesday, July 29, the United States Court of Appeals for the Second Circuit “clarified certain aspects of [its] false advertising jurisprudence” and held that, where literal falsity and deliberate deception have been proved in a market with only two players, it is appropriate to use...

 


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