James W. Huston

James W. Huston

Morrison & Foerster LLP

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Weeks II: Innovator Liability Finds a Sweet Home in Alabama

Last week, the Supreme Court of Alabama confirmed its January 2013 holding that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15,...more

8/21/2014 - Drug Manufacturers Generic Drugs Innovation Pharmaceutical Prescription Drugs

The Ghosts of Litigation Holds Past

Earlier this year, in the widely followed In re: Actos (Pioglitazone) Products Liability Litigation matter, a Louisiana federal jury ordered a drug manufacturer to pay $6 billion in punitive damages and $1.5 million in actual...more

7/25/2014 - Damages Drug Manufacturers Litigation Hold Manufacturers Multidistrict Litigation Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Punitive Damages Spoliation

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

6/18/2014 - Adverse Events Databases FDA FOIA HHS openFDA Pharmaceutical Prescription Drugs Reporting Requirements Transparency

“Brand” New Law: Illinois Court Holds Brand Manufacturers Owe Duty of Care to Generic Users

Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more

3/17/2014 - Brand Generic Drugs GlaxoSmithKline Pharmaceutical Prescription Drugs

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

3/14/2014 - FDA Generic Drugs Labeling Pharmaceutical Prescription Drugs

Lance v. Wyeth: A New Cause of Action in Pennsylvania?

Issuing an opinion over two years after oral argument, the Pennsylvania Supreme Court ruled last week in Lance v. Wyeth that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs....more

1/29/2014 - Drug Manufacturers Manufacturing Defects Marketing Negligence Prescription Drugs Wyeth

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

11/14/2013 - Drug Manufacturers FDA Generic Pharmaceutical Preemption Prescription Drugs

A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

8/7/2013 - DNA Drug Manufacturers Genetic Materials Human Genes Pharmaceutical

Mutual v. Bartlett Further Shields Generic Drug Manufacturers from Liability

Yesterday, the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

6/25/2013 - Design Defects Generic Drugs Mutual Pharmaceuticals v Bartlett Preemption Prescription Drugs SCOTUS Warning Labels

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

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

4/8/2013 - Failure To Warn FDA FDCA Generic Drugs Labeling Manufacturers PLIVA v Mensing Preemption SCOTUS

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

Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more

3/15/2013 - Drug Manufacturers Failure To Warn FDCA Generic Drugs Labeling PLIVA v Mensing Preemption

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

1/18/2013 - Drug Manufacturers Failure To Warn Generic Drugs Inc v Weeks Manufacturers Mensing Pharmaceutical Wyeth

Supreme Court to Hear Design Defect Preemption Case

Generic drug manufacturers were encouraged on Friday when the Supreme Court granted certiorari in the case of Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit, Bartlett v. Mutual Pham. Co.,...more

12/4/2012 - Design Defects Drug Manufacturers Generic Drugs Labeling Preemption SCOTUS

Lone Pine Order Forces Plaintiffs to Ante Up

Last week, the court in In re: Fosamax Products Liability Litigation granted Defendant Merck & Co.’s motion for a Lone Pine order. No. 06 MD 1789 (S.D.N.Y. Nov. 20, 2012). Lone Pine orders are valuable tools in defending mass...more

11/30/2012 - Evidence Expert Witness Lone Pine Order

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