Preemption Design Defects

News & Analysis as of

SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

California Dreaming: The Bite of Bauman, the Perfume of Preemption, the Stink of Stengel

This week the Drug and Device Law Son turns 20. It is apparently an age of discontent, of gripes and snipes. When we asked the DDLS what he wanted for his birthday, he said he wanted to move "back" to California. Something...more

Guest Post - Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

Today we have a guest post (her second - she's a glutton for punishment) from fellow Reed Smith associate Danielle Devens. This one brings together recent precedent recognizing post-Levine preemption in cases involving...more

Product Liability Update - July 2015

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

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

Product Liability Update - July 2013

Included in this Issue: ..United States Supreme Court Reverses First Circuit and Holds Federal Food Drug & Cosmetic Act Preempts Design Defect Claims against Generic Pharmaceutical Manufacturers ..United States...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

U.S. Supreme Court Bartlett Decision in Favor of Generic Drug Manufacturers

In a 5-4 decision, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug's...more

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

"Supreme Court’s Bartlett Decision Reaffirms Broad Scope of Generic Drug Preemption"

In a significant victory for generic drug companies, the Supreme Court today issued its decision in Mutual Pharmaceutical Co. v. Bartlett, reversing the decision of the First Circuit, which had affirmed a multimillion dollar...more

Supreme Court Hears Bartlett, Will Resolve Liability Questions for “Design-Defect” of Generic Drugs

In March, the U.S. Supreme Court held oral argument in Mutual Pharmaceutical Co. v. Bartlett, concerning whether design-defect claims against generic drug companies are preempted by federal law. Although the case addresses...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

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

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

Supreme Court Sides With Vaccine Manufacturers; State-Law Design Defect Claims Preempted

The U.S. Supreme Court, in a 6-2 decision, ruled that the National Childhood Vaccine Act of 1986 (NCVIA) preempts state-law design defect claims against vaccine manufacturers. [See Bruesewitz v. Wyeth LLC, FKA Wyeth, Inc.]...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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