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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.

 

HTMLWisconsin Court of Appeals Provides a Lesson in Documenting the Settlement
Rachel M. Blise; Foley & Lardner LLP;
Legal Alert/Article
September 23, 2014, previously published on September 22, 2014
A recent case from the Wisconsin Court of Appeals demonstrates the necessity of properly documenting the details of a settlement after agreement is reached on the amount. In Singler v. Zurich American Insurance Co., 2014AP391, Robert Singler and Zurich American Insurance Co. agreed to settle...

 

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...

 

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.

 

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...

 

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...

 

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...

 

HTMLNo Bones About It: Tenth Circuit Permits Narrowest Market Definition and Raises the Bar for an Entry Defense When Reinstating Monopolization Suit
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 15, 2014, previously published on August 11, 2014
On August 5, 2014, the Tenth Circuit Court of Appeals reinstated claims of monopolization and attempted monopolization under Section 2 of the Sherman Act brought by a manufacturer of surgical bone mills against a competitor. In reversing the district court's grant of summary judgment for the...

 


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