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HTMLA Rare Decertification Decision from the BCCA Stands: No Leave to Appeal Wakelam
Jill Yates; McCarthy Tétrault LLP;
Legal Alert/Article
October 8, 2014, previously published on September 5, 2014
The Supreme Court of Canada yesterday refused the plaintiff’s application for leave to appeal the British Columbia Court of Appeal’s decertification decision in Wakelam v. Wyeth et al. Wakelam is a claim against various manufacturers of children’s cough and cold medication for...

 

HTMLRecent Product Recalls
Jonathan Berman, Colleen Heisey, Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
September 23, 2014, previously published on September 2014
Recent food recalls involved undeclared allergens, microbial and foreign material contaminations, and choking hazards.

 

HTMLRecent Warning Letters
Jonathan Berman, Colleen Heisey, Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
September 23, 2014, previously published on September 2014
Since the last Update, FDA posted warning letters to two canning companies for various violations, including packaging food in insanitary conditions and failing to submit scheduled processes to FDA.

 

HTMLFDA Deputy Commissioner: Agency Focusing on Coordinated Food Safety and Specialized Inspectors
Jonathan Berman, Colleen Heisey, Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
September 23, 2014, previously published on September 2014
FDA continues to pursue a modern approach to food safety, as the agency adds specialized inspectors and develops new policies under the Food Safety Modernization Act. Mike Taylor, FDA's deputy commissioner for food, addressed a group of produce industry leaders earlier this month at the United...

 

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...

 

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...

 

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...

 

HTMLSham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?
Robert L. Magielnicki; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 19, 2014, previously published on August 12, 2014
Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may harm competition or competitors. The Supreme Court has...

 

HTMLFDA to focus on Laboratory Developed Tests
McDonald Hopkins LLC;
Legal Alert/Article
August 19, 2014, previously published on August 13, 2014
The Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 of its intent to issue draft guidance regarding regulatory oversight of laboratory developed tests (LDTs), including reporting and premarket submission requirements. The FDA treats LDTs as a subset of in vitro...

 

Adobe PDFMost Favored Nation Clauses: Do they Limit Free Competition or are they Pro Competitive?
Claudio Lizana, Lorena Pavic; Carey;
Legal Alert/Article
August 15, 2014
Recently, the U.S. Department of Justice ("DOJ") began reviewing a number of contracts which it calls "contracts that reference rivals". One type of such contracts is those containing Most Favored Nation Clauses ("MFN Clauses").

 


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