News & Analysis as of

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

Some Ideas About 3D Printing

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall. The article indicates...more

Liability for Pharmaceutical Manufacturers Expands for the First Time to Include Design Defect Claims

Product liability law in Pennsylvania has been fundamentally altered as it relates to the manufacturing and selling of prescription drugs. Manufacturers are now subject to design defect claims following a recent state Supreme...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

Pre-Emption of State-Law Design-Defect Claim Against Generic Drug Company

On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more

Generic Drug Preemption Expanded by Supreme Court's Bartlett Decision

Not surprisingly, the Supreme Court reaffirmed the broad preemptive scope of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and further extended the reach of impossibility preemption to design defect claims, in issuing its...more

DePuy Wants to Slip Away From Metal Hip Jury Verdict

Johnson & Johnson (J&J) has requested that an $8.3 million judgment against the company over its DePuy metal-on-metal (MoM) hip implant be put on hold....more

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

Design Defect Claims Against Vaccine Manufacturers Are Preempted by Federal Law

On February 22, 2011, in Bruesewitz v. Wyeth, Inc., the U.S. Supreme Court held in a 7–2 decision that the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) preempts all design defect claims brought against...more

Another Liability Shield for Vaccine Manufacturers: U.S. Supreme Court Rules that Design Defect Claims Against Vaccine...

On February 22, the Supreme Court issued its decision in Bruesewitz v. Wyeth, 562 U.S. __ (2011). The Court’s 6-2 opinion, written by Justice Scalia (Justice Kagan took no part in the decision), held that design defect claims...more

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