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Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

5/16/2013 - Abbott Laboratories Dear Doctor Letters Drug Manufacturers Failure To Warn FDA Pharmaceutical Prescription Drugs

Breaking Down The Bartlett Oral Argument

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

4/5/2013 - Design Defects FDA Generic Drugs Manufacturers Preemption SCOTUS Warning Labels

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...more

3/28/2013 - FDCA Medical Devices Negligence Per Se Parallel Claims Preemption

Driving on Both Sides of the Road: Supreme Court Hears Bartlett Oral Argument

The Supreme Court heard oral argument yesterday in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

3/21/2013 - Design Defects Generic Drugs Manufacturers Mutual Pharmaceuticals v Bartlett Preemption SCOTUS

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

1/15/2013 - Drug Manufacturers FDA FDCA Generic Drugs Manufacturers Medical Device Amendments Medical Devices Medtronics Mensing Preemption

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